MAUDE Adverse Event Report: ZIMMER GMBH METASUL® LDH®, HEAD ADAPTER, M, 0, TAPER 12/14-18/20; PROSTHESIS, HIP.

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Osseointegration Problem (3003)

Patient Problems Inadequate Osseointegration (2646); Metal Related Pathology (4530)

Event Date 12/08/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent revision operation due to loose cup and possible metallosis, approximately thirteen (13) years four (4) months from initial implantation.Metallosis was confirmed intraoperatively.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).G2: report source us multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00627, 0009613350-2024-00129.The cup, the head and the head adaptor were returned for investigation.All three item show signs in the form of scratches and nicks, most probably due to the revision surgery.The anchoring surface of the shell shows no bone ongrowth.The articulating surfaces of the shell and the head show some discoloration zone, most likely due to an uneven distribution of contact load in different areas.The taper surface of the head adaptor shows signs of fretting corrosion, most probably due to the contact with the stem taper.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 complaint trending process in order to identify potential adverse trends.Medical records were received and reviewed by a health care professional.Patient is female and was born in 1971.The patient underwent an initial left tha due to rheumatoid arthritis.Surgical notes of this procedure report very thin anterior-inferior acetabular wall and protrusion of the acetabulum that alters the normal anatomy.The patient underwent revision surgery due to loosening of the cup and metal related pathology.Surgical notes of this procedure report presence of brown fluid upon hip incision and presence of dark tissue in the joint consistent with local adverse reaction from metal on metal disease.The cup was found loose while on the head adaptor taper and the taper of the stem signs of wearing were found.Most likely root cause for the reported event is inappropriate use/implantation of the product.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: METASUL® LDH®, HEAD ADAPTER, M, 0, TAPER 12/14-18/20
• Type of Device: PROSTHESIS, HIP.
• 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: 19044404
• MDR Text Key: 339431371
• Report Number: 0009613350-2024-00130
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 0100185146
• Device Lot Number: 2385715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2007
• 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
• Treatment: ACETABULAR RESTRICTOR; VERSYS HIP SYSTEM FEMORAL STEM
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female