MAUDE Adverse Event Report: ZIMMER GMBH INVERSE/REVERSE SCREW SYSTEM, 4.5-18; ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM

Catalog Number 01.04223.018

Device Problems Material Deformation (2976); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 11/10/2015

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices for review.X-ray pictures were received and will be reviewed within the investigation.Where lot numbers were received for the device, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).Note: this is a split case with zimmer inc., (b)(4) reference number (b)(4) (mfr 1822565-2015-02698, tm liner).

Event Description

It was reported that the patient was implanted an inverse/reverse screw system, 4.5-18 on (b)(6) 2015.It was reported that the patient hit the door and had to be revised on (b)(6) 2015.It was observed that the glenosphere was not in place and the polyethylene was deformed.

Manufacturer Narrative

Additonal information was received on february 9, 2016.As soon as additional information become available and an investigation result be available an updated report will be submitted.(b)(4).

Event Description

It became aware on (b)(6) 2016 that the screws remain in the patient because were not affected.

Manufacturer Narrative

As per fda¿s directive, medwatch report has been resubmitted for removing three zeros in the prefix of mfr number(0009613350-2016-00134-2).All the information captured as per 0009613350-2016-00134 - 2 including g4(date received by manufacturer) except b4.It was reported that a tsa was implanted on t august 11, 2015 and a partial revision was performed on the october 11, 2015 due to bent liner (see cpt150034287 - mfr 1822565-2015-02698).The screws were not revised.No trend identified.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.X-rays dated (b)(6) 2015: ap- view of the left shoulder.No signs of loosening around the screws.The screws seemed to be well implanted.X-rays dated (b)(6) 2015: similar to the picture taken on october, again an ap- view of the left shoulder.No signs of loosening around the screws.The screws seemed to be well implanted.The product was not received for investigation because still implanted.Review of the x-rays did not reveal any issue related to the inverse/reverse screws system.The reported event stated that the liner was found to be bent and this event is not related to the screws.However, all possible causes related to the issues reported are listed in the dfmea which is available for every zimmer implant and is continuously monitored and updated.The product was not involved in the event.No failure detected and therefore no root cause found.The need for corrective actions is not indicated and zimmer gmbh considers this case as closed.Zimmer's reference number of this file is (b)(4).

Event Description

Patient underwent revision due to a bent liner.

• Brand Name: INVERSE/REVERSE SCREW SYSTEM, 4.5-18
• Type of Device: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
• Manufacturer (Section D): ZIMMER GMBH; sulzerallee 8; winterthur, 8404 ; SZ 8404
• MDR Report Key: 5409412
• MDR Text Key: 37425706
• Report Number: 9613350-2016-00134
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 01.04223.018
• Device Lot Number: 2742810
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 75