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

Model Number N/A

Device Problems Degraded (1153); Biocompatibility (2886); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Cyst(s) (1800); Bone Fracture(s) (1870); Muscle Weakness (1967); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 04/18/2018

Event Type  Injury  

Manufacturer Narrative

Medical products: femoral stem press-fit collarless 12/14 neck taper standard body standard neck offset size 13 138mm. Stem length cementless; catalog#: 00-7864-013-00; lot#: 61256425. Therapy date: (b)(6) 2018. The manufacturer received other source documents for review. 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 multiple complications which were as follows: aseptic lymphocyte-dominant vasculitis- associated lesion (alval). Pelvic ring fracture (patient bone fracture). Hip muscle weakness and muscle destruction related to alval. Cobalt and chromium ion reaction - type 4. Large pseudocyst with approximately a liter of fluid that was slightly green-tinged consistent with alval. Extensive trunnionosis with a blackened trunnion. Fibrous component on the acetabular component and along the pelvis ring fracture. There was approximately 2000ml blood loss during revision surgery. The patient was given 2 units of packed red blood cells and 2 units of ffp.

• Brand Name: METASUL LDH, HEAD ADAPTER, M, 0, TAPER 12/14-18/20
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 11874791
• MDR Text Key: 252628237
• Report Number: 0009613350-2021-00234
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00889024422544
• UDI-Public: (01)00889024422544(17)140531(10)2516387
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 01.00185.146
• Device Lot Number: 2516387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2009
• 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 Treatment Data

Date Received: 05/25/2021 Patient Sequence Number: 1