MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 FP TYPE1 PPS HO 6.0; PROSTHESIS, HIP

Catalog Number	51-101060
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during an inspection of the circulated items in stock, the inner pouch was found to be torn.There was no patient involvement.It was reported that no additional information is available.
Event or Problem Description
Upon reassessment of the reported event, it has been determined that the device sterility has not been compromised.The initial report was forwarded in error and should be voided.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it has been determined that the device sterility has not been compromised.The initial report was forwarded in error and should be voided.

• Brand Name: TPRLC 133 FP TYPE1 PPS HO 6.0
• 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: 15961847
• Report Number: 0001825034-2022-02757
• Device Sequence Number: 4938650
• Product Code: KWA
• UDI-Device Identifier: 00880304499072
• UDI-Public: (01)00880304499072(17)270803(10)6095455
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2023

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: 51-101060
• Device Lot Number: 6095455
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 11/25/2022
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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