MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METALGLENOID COMPONENT; TM GLENOID

Catalog Number 00432604000

Device Problems Device Slipped (1584); Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation in progress.

Event Description

Revision due to loosening.Trabecular metal glenoid component is only the tmt design control part.

Manufacturer Narrative

The explanted tm glenoid was returned for this investigation.The device appears grossly intact.The tm portion of the device appears as expected except minimal tissue ingrowth is suspected.White powdery specs are present and located mostly towards the spherical tips of the tm keel).Its origin is unknown but is suspected to be a by-product of the in-house disinfection process using spor-klenz.The poly articulating surface appears not as expected.A scratch spanning from the superior or inferior edge (can not be more specific since in-vivo tm glenoid orientation is unknown) of the articulating surface to its center is seen.A wear pattern is located along the anterior or posterior edge.The edge of the poly articulating surface appears rolled-over at two locations near the wear pattern.The wear pattern and rolled-over edges may be indicative of edge loading by the humeral head on the tm glenoid rim.Two gouges along the anterior or posterior edge of the articulating surface are noted.One gouge is biased towards the superior edge while the other is biased towards the inferior edge.The origin of the gouges is unknown.No imaging report from an independent radiologist was provided for review in this investigation.Therefore, engineering review of the single x-ray image showing an unidentified left shoulder was limited to confirming that a tm glenoid keel (poly is radiolucent on x-ray) was present.The mating humeral head was identified as a sidus stem-free shoulder humeral head size 38-13.Per the surgical technique and compatibility document, only the sidus stem-free shoulder humeral anchor when used with a bigliani/flatow humeral head is compatible with the tm glenoid, the tm glenoid is not compatible with the sidus stem-free shoulder humeral head that was implanted according to the patient labels.The incompatibility between the tm glenoid and the mating humeral head may have been a factor that contributed to the tm glenoid dislodging.There is no evidence however that suggests anything in the design or manufacture of the tm glenoid itself contributed to the device dislodging.This investigation by product development is considered closed at this time.However, if additional information becomes available, this investigation can be re-opened.Updated (adverse event and product malfunction) , ( pain) , (patient code -after revision pain).

Event Description

The surgeon completed the primary left anatomical shoulder implant, using the sidus humeral system with the tm gleniod system on (b)(6) 2015.The surgery was completed in accordance with the zimmerbiomet operation technique.The end results showed a good stable fixation and the patient was discharged after the routine follow up.On (b)(6) 2018, the patient presented at the surgeons clinic with new pain and decreased range of movement.The patient explained that whilst conducting normal movement of the arm, a loud #crack# was heard and felt in the patient#s left shoulder, resulting in the new pain and reduced range of movement.The patient was examined by the surgeon, who suspected implant failure, organised an x-ray and ct scan of the patient#s left shoulder.The patient returned to clinic on (b)(6) 2018, where the surgeon confirmed glenoid implant loosening, from the xray and ct scan images.The tm glenoid implant, appeared to have twisted on the patient glenoid articular surface.Blood tests and examination provided no evidence of infection.The patient was admitted for revision surgery on (b)(6) 2018.On dissecting down to the patients glenoid, the diagnosis of glenoid implant loosening was confirmed.The implant had twisted, causing a cavity in the patient's glenoid articular surface.Tissue specimens were taken to test for any infection around the implant, the results have yet to be confirmed.The implant came away from the glenoid without effort.Then the glenoid was prepared for the replacement cemented hybrid glenoid, which was implanted without complication.The original sidus humeral head was removed and a like for like replacement implanted.Patient impact: the patient complained of pain resulting in a decreased range of movement and lasting just over six months.The patient had a second general anaesthetic and revision surgery.

Event Description

The surgeon completed the primary left anatomical shoulder implant, using the sidus humeral system with the tm gleniod system on (b)(6) 2015.The surgery was completed in accordance with the zimmer biomet operation technique.The end results showed a good stable fixation and the patient was discharged after the routine follow up.On 8th may 2018, the patient presented at the surgeons clinic with new pain and decreased range of movement.The patient explained that whilst conducting normal movement of the arm, a loud crack was heard and felt in the patients left shoulder, resulting in the new pain and reduced range of movement.The patient was examined by the surgeon, who suspected implant failure, organized an x-ray and ct scan of the patients left shoulder.The patient returned to clinic on (b)(6) 2018, where the surgeon confirmed glenoid implant loosening, from the xray and ct scan images.The tm glenoid implant, appeared to have twisted on the patient glenoid articular surface.Blood tests and examination provided no evidence of infection.The patient was admitted for revision surgery on (b)(6) 2018.On dissecting down to the patient#s glenoid, the diagnosis of glenoid implant loosening was confirmed.The implant had twisted, causing a cavity in the patient's glenoid articular surface.Tissue specimens were taken to test for any infection around the implant, the results have yet to be confirmed.The implant came away from the glenoid without effort.The glenoid was prepared for the replacement cemented hybrid glenoid, which was implanted without complication.The original sidus humeral head was removed and a like for like replacement implanted.Patient impact: the patient complained of pain resulting in a decreased range of movement and lasting just over six months.The patient had a second general anaesthetic and revision surgery.

Manufacturer Narrative

According to the complaint description, a load crack in the shoulder caused the patient to suffer pain and reduce range of motion.This lead to the tm-glenoid becoming loose.The exact cause for the tm-glenoid becoming loose is unknown, however the hazard can be attributed to mechanical failure.This failure should be added as a new line item in dra-rmf 124.No device was returned for evaluation, therefore only a device history review was performed.Device history records were reviewed for the glenoid component part number 00432604000 and lot number 62371558, and no deviations or anomalies were found.A review of the implant's manufacturing record indicates that it was manufactured to specification.Based on the information available, the root cause of the event cannot be determined.Should additional information be obtained to further this investigation, this report shall be updated.

Manufacturer Narrative

Please refer - mfr report# 3005751028 - 2018 - 00076 -3 for manufacturing narratives.(b)(4).

Event Description

The surgeon completed the primary left anatomical shoulder implant, using the sidus humeral system with the tm gleniod system on (b)(6) 2015.The surgery was completed in accordance with the zimmerbiomet operation technique.The end results showed a good stable fixation and the patient was discharged after the routine follow up.On (b)(6) 2018, the patient presented at the surgeons clinic with new pain and decreased range of movement.The patient explained that whilst conducting normal movement of the arm, a loud #crack# was heard and felt in the patient#s left shoulder, resulting in the new pain and reduced range of movement.The patient was examined by the surgeon, who suspected implant failure, organised an x-ray and ct scan of the patient#s left shoulder.The patient returned to clinic on 21st august 2018, where the surgeon confirmed glenoid implant loosening, from the xray and ct scan images.The tm glenoid implant, appeared to have twisted on the patient glenoid articular surface.Blood tests and examination provided no evidence of infection.The patient was admitted for revision surgery on (b)(6) 2018.On dissecting down to the the patient#s glenoid, the diagnosis of glenoid implant loosening was confirmed.The implant had twisted, causing a cavity in the patient#s glenoid articular surface.Tissue specimens were taken to test for any infection around the implant, the results have yet to be confirmed.The implant came away from the glenoid without effort.The the glenoid was prepared for the replacement cemented hybrid glenoid, which was implanted without complication.The original sidus humeral head was removed and a like for like replacement implanted.Patient impact: the patient complained of pain resulting in a decreased range of movement and lasting just over six months.The patient had a second general anaesthetic and revision surgery.

Manufacturer Narrative

Updated.Update the device code as per the rgd.

Event Description

The surgeon completed the primary left anatomical shoulder implant, using the sidus humeral system with the tm gleniod system on (b)(6) 2015.The surgery was completed in accordance with the zimmerbiomet operation technique.The end results showed a good stable fixation and the patient was discharged after the routine follow up.On (b)(6) 2018, the patient presented at the surgeons clinic with new pain and decreased range of movement.The patient explained that whilst conducting normal movement of the arm, a loud #crack# was heard and felt in the patient#s left shoulder, resulting in the new pain and reduced range of movement.The patient was examined by the surgeon, who suspected implant failure, organised an x-ray and ct scan of the patient#s left shoulder.The patient returned to clinic on (b)(6) 2018, where the surgeon confirmed glenoid implant loosening, from the xray and ct scan images.The tm glenoid implant, appeared to have twisted on the patient glenoid articular surface.Blood tests and examination provided no evidence of infection.The patient was admitted for revision surgery on 22nd november 2018.On dissecting down to the the patient#s glenoid, the diagnosis of glenoid implant loosening was confirmed.The implant had twisted, causing a cavity in the patient#s glenoid articular surface.Tissue specimens were taken to test for any infection around the implant, the results have yet to be confirmed.The implant came away from the glenoid without effort.The the glenoid was prepared for the replacement cemented hybrid glenoid, which was implanted without complication.The original sidus humeral head was removed and a like for like replacement implanted.Patient impact: the patient complained of pain resulting in a decreased range of movement and lasting just over six months.The patient had a second general anaesthetic and revision surgery.

Event Description

The surgeon completed the primary left anatomical shoulder implant, using the sidus humeral system with the tm gleniod system on (b)(6) 2015.The surgery was completed in accordance with the zimmerbiomet operation technique.The end results showed a good stable fixation and the patient was discharged after the routine follow up.On 8th may 2018, the patient presented at the surgeons clinic with new pain and decreased range of movement.The patient explained that whilst conducting normal movement of the arm, a loud crack¿ was heard and felt in the patient¿s left shoulder, resulting in the new pain and reduced range of movement.The patient was examined by the surgeon, who suspected implant failure, organised an x-ray and ct scan of the patient¿s left shoulder.The patient returned to clinic on (b)(6) 2018, where the surgeon confirmed glenoid implant loosening, from the xray and ct scan images.The tm glenoid implant, appeared to have twisted on the patient glenoid articular surface.Blood tests and examination provided no evidence of infection.The patient was admitted for revision surgery on (b)(6) 2018.On dissecting down to the patient¿s glenoid, the diagnosis of glenoid implant loosening was confirmed.The implant had twisted, causing a cavity in the patient¿s glenoid articular surface.Tissue specimens were taken to test for any infection around the implant, the results have yet to be confirmed.The implant came away from the glenoid without effort.The glenoid was prepared for the replacement cemented hybrid glenoid, which was implanted without complication.The original sidus humeral head was removed and a like for like replacement implanted.Patient impact: the patient complained of pain resulting in a decreased range of movement and lasting just over six months.The patient had a second general anaesthetic and revision surgery.

Event Description

The surgeon completed the primary left anatomical shoulder implant, using the sidus humeral system with the tm gleniod system on (b)(6) 2015.The surgery was completed in accordance with the zimmerbiomet operation technique.The end results showed a good stable fixation and the patient was discharged after the routine follow up.On (b)(6) 2018, the patient presented at the surgeons clinic with new pain and decreased range of movement.The patient explained that whilst conducting normal movement of the arm, a loud #crack# was heard and felt in the patient#s left shoulder, resulting in the new pain and reduced range of movement.The patient was examined by the surgeon, who suspected implant failure, organised an x-ray and ct scan of the patient#s left shoulder.The patient returned to clinic on (b)(6) 2018, where the surgeon confirmed glenoid implant loosening, from the xray and ct scan images.The tm glenoid implant, appeared to have twisted on the patient glenoid articular surface.Blood tests and examination provided no evidence of infection.The patient was admitted for revision surgery on (b)(6) 2018.On dissecting down to the patient#s glenoid, the diagnosis of glenoid implant loosening was confirmed.The implant had twisted, causing a cavity in the patient#s glenoid articular surface.Tissue specimens were taken to test for any infection around the implant, the results have yet to be confirmed.The implant came away from the glenoid without effort.The glenoid was prepared for the replacement cemented hybrid glenoid, which was implanted without complication.The original sidus humeral head was removed and a like for like replacement implanted.Patient impact: the patient complained of pain resulting in a decreased range of movement and lasting just over six months.The patient had a second general anaesthetic and revision surgery.

Manufacturer Narrative

According to the complaint description, a load crack in the shoulder caused the patient to suffer pain and reduce range of motion.This lead to the tm-glenoid becoming loose.The exact cause for the tm-glenoid becoming loose is unknown, however the hazard can be attributed to mechanical failure.Device history records were reviewed for the glenoid component part number 00432604000 and lot number 62371558, and no deviations or anomalies were found.A review of the implant's manufacturing record indicates that it was manufactured to specification.Based on the information available, the root cause of the event cannot be determined.Should additional information be obtained to further this investigation, this report shall be updated.Document in support of product evaluation summery (b)(4) attached.- attachment: [evaluation summary (b)(4).Pdf].

• Brand Name: TRABECULAR METALGLENOID COMPONENT
• Type of Device: TM GLENOID
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 8167252
• MDR Text Key: 130459303
• Report Number: 3005751028-2018-00076
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K071090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 00432604000
• Device Lot Number: 62371558
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention