MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR MP FP T1 PPS 6X97.5MM; PROSTHESIS, HIP

Catalog Number 51-149060

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed a follow-up mdr will be submitted report source: (b)(6).

Event Description

It was reported that during inspection at the distributorship a team member discovered hair like debris in sterile packaging.No adverse consequences reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The reported event is confirmed.Evaluation of the returned product confirmed foreign debris is present inside the sterile packaging, and the sterile packaging remains sealed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The likely condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the reported event is the operator not following the provided work instructions during manufacturing.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.

Event Description

No additional information on the reported event.

• Brand Name: TPRLC XR MP FP T1 PPS 6X97.5MM
• 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: 13451062
• MDR Text Key: 287825673
• Report Number: 0001825034-2022-00275
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00880304517431
• UDI-Public: (01)00880304517431(17)310922(10)7109729
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 51-149060
• Device Lot Number: 7109729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1