MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-42; ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978); Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)

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

Event Date 04/06/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: anatomical shoulder reverse, screw system, 4.5-36; catalog#: 01.04223.036; lot#: 3006651.Base plate 25 mm post length +2 mm lateral offset uncemented; catalog#: 00-4349-025-02; lot#: 64351007.Glenosphere 36 mm diameter; catalog#: 00-4349-036-11; lot#: 64367752.Anatomical shoulder reverse, humeral cup, retro, +6 mm medial offset; catalog#: 01.04223.106; lot#: 3004536.Anatomical shoulder reverse, humeral insert, pe, 36-3; catalog#: 01.04223.363; lot#: 3006738.Therapy date: (b)(6) 2021.The manufacturer did receive x-rays for review.Other documents were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, 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 supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on the right side and underwent revision due to pain, loosening and implant fracture.

Manufacturer Narrative

D10: medical products: anatomical shoulder reverse, screw system, 4.5-36; catalog#: 01.04223.036; lot#: 3006651 base plate 25 mm post length +2 mm lateral offset uncemented; catalog#: 00-4349-025-02; lot#: 64351007 glenosphere 36 mm diameter; catalog#: 00-4349-036-11; lot#: 64367752 anatomical shoulder reverse, humeral cup, retro, +6 mm medial offset; catalog#: 01.04223.106; lot#: 3004536 anatomical shoulder reverse, humeral insert, pe, 36-3; catalog#: 01.04223.363; lot#: 3006738 anatomical shoulder, humeral stem, uncemented, 14, 100 mm; catalog#: 01.04201.143; lot#: 2996924 therapy date: (b)(6) 2021 this follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additional information was received on (b)(6), 2021 additional: a2, d10 correction: b4, g3, g6, h2, h10 the manufacturer received other source documents for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on the right side and underwent revision due to pain, loosening and implant fracture.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Additional: h2, h6.Correction: b4, g3, g6, h10.Event description: it was reported that the patient received the implant on (b)(6), 2019 and the patient started experiencing pain post implantation.After preliminary examination on (b)(6), 2021 by dr.(b)(6), it was reported that the tm glenoid baseplate was loosened along with screw fracture.It was also reported that patient underwent revision surgery on (b)(6) 2021 due to pain, loosening and implant fracture.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: the x-ray review shows an abnormally angulated glenoid fixation screw that appears fractured.Overall alighnment is maintained.There is a small amount of lucency at the osseous margin of the glenoid baseplate.Bone quality is osteopenic.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Ncr(s): no ncr with a potential correlation to the reported event was found.Conclusion: it was reported that the patient received the implant on (b)(6), 2019 and the patient started experiencing pain post implantation.After preliminary examination on (b)(6), 2021 by dr.(b)(6), it was reported that the tm glenoid baseplate was loosened along with screw fracture,it was also reported that.Patient underwent revision surgery on (b)(6), 2021 due to pain, loosening and implant fracture.Based on the investigation the reported event can be confirmed for one screw.However, it is unknown which screw is the one that fractured.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

• Brand Name: ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-42
• Type of Device: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11691716
• MDR Text Key: 251385739
• Report Number: 0009613350-2021-00175
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 00889024483057
• UDI-Public: 00889024483057
• Combination Product (y/n): N
• PMA/PMN Number: K052906
• 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: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 01.04223.042
• Device Lot Number: 2985867
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE; SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR