MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HIP-OTHER-HEADS-UNK; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unknown month and day in 1991.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the part and lot number of the device involved in the event is unknown.Root cause was unable to be determined.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-02688, 0001822565-2021-02689, 0001822565-2021-02691.

Event Description

It was reported that the patient underwent a revision procedure approximately 30 years post implantation due to pain and osteolysis.No further event information available at the time of this report.

• Brand Name: HIP-OTHER-HEADS-UNK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12482066
• MDR Text Key: 271719542
• Report Number: 0001822565-2021-02690
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2021
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: CAT#: 00652805800 ZIMMER CUP LOT#: 63727000; UNKNOWN LINER; UNKNOWN STEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 79