MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR T1 PPS 13X146MM; PROSTHESIS, HIP

Catalog Number	51-105130
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00346, 0001825034-2023-00347, 0001825034-2023-00348 and 0001825034-2023-00349.Report source: 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 or Problem Description
It was reported while inspecting the circulating items in stock, the sterile packaging was found to be damaged.There was no patient involvement.It was reported that no additional information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b4, b5, g3; h2; h3; h6.Visual evaluations of the returned product/provided photo(s) identified damage to the sterile packaging (blister).Sterility has not been compromised.Reported event has been confirmed by evaluation of the returned product.Dhr was reviewed and no discrepancies related to the reported event were found.The product was found to be conforming and sterility was not compromised.Therefore, this is no longer reportable.Investigation results concluded that the reported event can be attributed to transit damage and a packaging design issue.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 or Problem Description
During the investigation of the reported event the product was found to be conforming and sterility was not compromised.Therefore, this is no longer a reportable event.

• Brand Name: TPRLC XR T1 PPS 13X146MM
• Common Device Name: PROSTHESIS, 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: 16392753
• Report Number: 0001825034-2023-00350
• Device Sequence Number: 20429182
• Product Code: LPH
• UDI-Device Identifier: 00880304517141
• UDI-Public: (01)00880304517141(17)300716(10)6820318
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 51-105130
• Device Lot Number: 6820318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown