MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN MAGNUM ACETABULUM CUP HIP PROTHESIS

Model Number N/A

Device Problems Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994); Osteolysis (2377)

Event Date 01/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4). Initial report. Report source, foreign - event occurred in (b)(6). We are waiting to hear whether the product is available to be returned to zimmer biomet for investigation. Medical product: unknown cobalt chrome head, catalog: unknown, lot: unknown. Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00547. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

The patient's legal counsel reported that the patient was implanted with an aura ii stem, a crco head and a magnum acetabulum on (b)(6) 2010. Following this total hip arthroplasty, the patient suffered from pain, however, he got back to professional life. On (b)(6) 2017, the patient fell and the prosthesis has decompensated. It was therefore seen through x-ray that the patient suffered from bipolar geodic reaction following a release of ions by the prothesis. Indeed, it was reported that the metal friction between the prothesis components has led to inflammatory granulomas with a phenomen of bone resorption. On (b)(6) 2020, the patient underwent a revision surgery to remove the prothesis. The delay observed between the fall on (b)(6) 2017 and the revision surgery can be explained by the implantation of a total hip prothesis on the left hip. This report is based on allegations set forth in patients notice and the allegations there in are unverified.

• Brand Name: UNKNOWN MAGNUM ACETABULUM CUP
• Type of Device: HIP PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11027346
• MDR Text Key: 222072412
• Report Number: 3002806535-2020-00546
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: UNK MAGNUM CUP
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Invalid Data
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 12/17/2020 Patient Sequence Number: 1