MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN LINER PROSTHESIS, HIP

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Joint Dislocation (2374); No Information (3190)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical products: item #: unknown, unknown head, lot #: unknown. Item #: unknown, unknown stem, lot #: unknown. Item #: unknown, unknown cup, lot #: unknown. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The product was discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-03607.

Event Description

It was reported patient underwent hip revision approximately 30 years post implantation due to unknown reasons. During the procedure, cup and liner components were removed and replaced. Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN LINER
• 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: 10718188
• MDR Text Key: 212508231
• Report Number: 0001822565-2020-03608
• 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

• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model 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: 11/18/2020
• 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: 10/22/2020 Patient Sequence Number: 1