MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER¢, GLENOID, PEGGED, CEMENTED, M; ANATOMICA GLENOID COMPONENT

Model Number N/A

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Date 12/07/2017

Event Type  Injury  

Manufacturer Narrative

Device is not expected, but investigation is in progress: the device will not be returned for analysis as it is still implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.The device history records were reviewed and found to be conforming.Clinical study was received and will be reviewed as part of ongoing investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that approximately 12 months post-op the patient experiences grade 1 of glenoid radiolucency and is being monitored.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: radiolucency.Event description: patient was implanted with as glenoid system on (b)(6) 2014 and being monitored due to grade 1 radiolucency.Review of received data: some x-rays were received.The review of the x-rays was done by a doctor.6 weeks postop.: external ap-view: slightly overexposed, no conspicuous in the area of the glenoid.Internal ap-view: in the area of the visible bony structures in the area of the glenoid irregularly represented bony structures in the area of the pegs.Axillary view: no noticeable changes in the area of the glenoid.6 months: external ap-view: 6 weeks postoperatively, qualitatively more transparent representation of the bony structures without comparatively conspicuous glenoidal structural changes.Internal ap-view: comparatively to the x-rays 6 weeks postoperatively, here qualitatively overexposed image, thus washed out bony structures without recognizable significant changes of the bony structures glenoidal.Axillary view: due to the overexposure no reliable assessment of the bony structures possible.12 months: external ap-view: comparable to the previous x-ray 6 months postoperative glenohumeral projection-related comparable assessment is not possible.In the area of the cranial glenoid half possible cystic radiolucency in the area of the uppermost peg.Internal ap-view: compared to the x-ray 6 months postoperatively here extensive overlay of the glenoid component, therefore no reliable assessment of the bony structures in the area of the glenoid possible.Axillary view: due to the overexposure no assessment of the bony structures in the area of the glenoid is possible.24 months: external view: suggested possible radiolucent line at the cranial glenoid rim.Internal view: compared to the preliminary x-rays no progressive changes of the recognizable bony structures in the area of the glenoid.Indicated two small, approximately 1-2mm large, circular radiolocencys on the cranial portion of the glenoid.Axillary view: the image is reversed, no noticeable progressive changes visible in the area of the glenoid.Unspecified view: overexposure image, no apparent bony structure changes in the glenoid area.36 months: external view: compared to the preliminary x-rays no progressive changes of the recognizable bony structures in the area of the glenoid.Internal view: compared to the preliminary x-rays no relevant progressive changes of the recognizable bony structures in the area of the glenoid.The crf report for study decribes that the patient was very satisfied, subjective shoulder value 100%.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: the compatibility check was performed from surgical technique and showed that the product combination was approved by zimmer biomet.Root cause analysis: root cause determination using sap rmw: magnet field indicated motion leading to aseptic loosening due to magnetically induced displacement force and torque not possible there is no information given about magnet field.Therefore, this step can be excluded.Impossibility of using mri scanning due to image artifacts not possible it is not reported that a mri was used.Implant loosening due to not possible the x-rays show correct sizing and positioning of the implants.Implant wear debris leading to device loosening through osteolysis due to exposure to the physiological environment results in wear of the implant device possible, the devices have not been returned for evaluation.Therefore, this point cannot be excluded.Mechanical loosening due to cemented fixation of the poly glenoid destabilises, leading to loosening of the prosthesis from the glenoid bone not possible the x-rays show correct sizing and positioning of the implants.Surgery failure (e.G.Aseptic loosening, fracture of implant, fracture of bone, wrong soft tissue balancing, etc.) due to missing or unclear information regarding cross compatibility between existing zimmer biomet systems and sizes not possible the implants are compatible.Aseptic loosening due to laser marking/engraving not readable in normal lighting conditions leads to use of wrong implant not possible there is no sign for a wrong used device.Surgery failure (e.G.Aseptic loosening, fracture of implant, fracture of bone, wrong soft tissue balancing, etc.) due to insufficient or overly complicated surgical technique not possible the event detail does not describe inconsistencies with the procedure in the surgical technique.Conclusion: according to the available information after implantation of an as glenoid system right on (b)(6) 2014 12 months postoperatively mentioned radioluncency grade i glenoidal and incomplete radiolucency around 1 or 2 pegs.Radiologically, the term "radiolucency" refers to a dark, i.E.More radiopaque region in the x-ray.Based on the work of mole et al, it can be classified into three degrees of severity: grade 1 (<1 mm), grade 2 (between 1 and 2 mm) and grade 3 (> 2mm).According to the available three x-rays 12 months postoperatively, radiolucency grade i on the glenoid and incomplete radiolucency around 1 or 2 pegs cannot be confirmed with certainty.On the provided x-rays it can be seen in the course from the 6th postoperative week to 3 years postoperatively on the glenoid no proven detectable, progressive changes or radiolucency.It should also be mentioned here that the patient was very satisfied 24 months postoperatively with a subjective shoulder value of 100%.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Refer to.

• Brand Name: ANATOMICAL SHOULDER¢, GLENOID, PEGGED, CEMENTED, M
• Type of Device: ANATOMICA GLENOID COMPONENT
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7539809
• MDR Text Key: 109099755
• Report Number: 0009613350-2018-00547
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: PK990136
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.04214.370
• Device Lot Number: 2761104
• Other Device ID Number: 00889024481008
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SIDUS ANCHOR, ITEM# 01.04555.120, LOT# 2767960; SIDUS HEAD, ITEM# 01.04555.440, LOT# 2757246; SIDUS ANCHOR, ITEM# 01.04555.120, LOT# 2767960; SIDUS HEAD, ITEM# 01.04555.440, LOT# 2757246
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 120