MAUDE Adverse Event Report: ZIMMER GMBH METASUL® DUROM®, COMPONENT FOR ACETABULUM, UNCEMENTED, 58/ø 52, CODE R; HIP IMPLANT

Model Number N/A

Device Problem Biocompatibility (2886)

Patient Problem Osteolysis (2377)

Event Date 10/24/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent revision surgery due to osteolysis pseudo tumor acetabulum right hip due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).G2: foreign: australia the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2023- 00630, 0009613350 - 2023- 00631, 0009613350 - 2023- 00632.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: g3; h2; h3; h6.Products were not returned for investigation, but pictures were provided.The articulating surface as well as the flat rim of the cup show some scratches; the outer surface presents some attached tissue.The visible flat surface of the head adapter shows some discoloration; the inner surface (the one in contact with the taper of the stem) shows what looks like signs of wear.The surfaces of the stem show some scratches and nicks; the taper of the stem shows signs of wear.The bevel of the head looks inconspicuous; some tissue remnants can be seen inside the head.Due to the low quality of the provided pictures a deeper and more accurate product evaluation cannot be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint histories identified additional similar complaints for the reported items and the part and lot combinations.Complaints are monitored per wt-wi 423801 complaint trending process in order to identify potential adverse trends.With the available information a definitive root cause cannot be established.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information at this time.

• Brand Name: METASUL® DUROM®, COMPONENT FOR ACETABULUM, UNCEMENTED, 58/ø 52, CODE R
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18153465
• MDR Text Key: 328322718
• Report Number: 0009613350-2023-00629
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K053536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2010
• Device Model Number: N/A
• Device Catalogue Number: 0100214058
• Device Lot Number: 2301535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 70 KG