MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR MP T1 PPS 14X113MM; PROTHESIS, HIP

Model Number N/A

Device Problem Packaging Problem (3007)

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

Event Date 03/23/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source foreign : japan.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by distributorship that the products were found to be nonconforming.Debris was found in the sterile package.There was no patient involvement.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Product was returned and evaluated.A visual evaluation of the returned product found foreign debris inside the sealed sterile packaging.This issue was confirmed through evaluation of the returned product.The reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.The reported event was not related to a combination of products; therefore, a compatibility review was not applicable.A review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The condition of the device was likely non-conforming to specification when it left zimmer biomet.The root cause of the reported event was operator error during inspection of the packaging for foreign materials.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 further event information is available at the time of this report.

• Brand Name: TPRLC XR MP T1 PPS 14X113MM
• Type of Device: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16735118
• MDR Text Key: 313260631
• Report Number: 0001825034-2023-00823
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304517332
• UDI-Public: (01)00880304517332(17)320811(10)7315056
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 51-145140
• Device Lot Number: 7315056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 07/11/2023
• Supplement Dates FDA Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2022
• 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