MAUDE Adverse Event Report: ZIMMER GMBH METASUL DUROM®, COMPONENT FOR ACETABULUM, UNCEMENTED, 50/ø 44; HIP IMPLANT

Model Number N/A

Device Problems Biocompatibility (2886); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Seroma (2069); Synovitis (2094); Osteolysis (2377); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 11/02/2022

Event Type  Injury  

Event Description

It was reported a patient had an initial right total hip arthroplasty.Subsequently, identified elevated cobalt levels and began to experience pain, limiting walking and approximately 16 years after implantation, the patient had a revision with the findings of trunnionosis, osteolysis around the greater trochanter and acetabulum, trochanteric bursitis, seroma with synovitis, and tissue damage of the trochanter major.Autologous spongiosa was used to repair the acetabulum and the stem remained implanted while the cup, head, and taper were all revised with competitor products.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).G2: foreign: germany.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 -2024 -00004, 0009613350 -2024 -00005, 0009613350 -2024 -00006.

Event Description

No additional information at this time.

Manufacturer Narrative

Products were not returned, but pictures of the explanted device during the revision surgery were provided.However, due to the low quality of the pictures and the presence of blood and tissue on the explants, an assessment of the products 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 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.

• Brand Name: METASUL DUROM®, COMPONENT FOR ACETABULUM, UNCEMENTED, 50/ø 44
• 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: 18438314
• MDR Text Key: 331829963
• Report Number: 0009613350-2024-00003
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K053536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

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: 09/15/2010
• Device Model Number: N/A
• Device Catalogue Number: 0100214050
• Device Lot Number: 2289299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2005
• 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: 74 YR
• Patient Sex: Female