MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR MP FP T1 PPS 7X99MM; PROSTHESIS, HIP

Catalog Number	51-149070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: japan.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported during a five year post-operative follow-up the x-ray showed the neck was sharply shaved off.A revision has not been scheduled at this time.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.D10: (b)(6) g7 osseoti 3 hole shell 48mm c (b)(6).(b)(6) g7 dual mobility liner 38mm c (b)(6).(b)(6) cer bioloxd option hd 28mm (b)(6).(b)(6) cer option type 1 tpr sleve -3 (b)(6).(b)(6) act artic e1 hip brg 28x38mm (b)(6).Component code: mechanical (g04) ¿ stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Unable to confirm complaint, based on provided x-rays a definite fracture could not be identified.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history found no additional related issues for this/these item(s) and the reported part and lot combination(s).Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: question a notched appearance of the femoral neck of a right total hip arthroplasty on the frog leg images, nonspecific.No signs of loosening, wear, radiolucency.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: TPRLC XR MP FP T1 PPS 7X99MM
• 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: 16691014
• Report Number: 0001825034-2023-00754
• Device Sequence Number: 5921121
• Product Code: LPH
• UDI-Device Identifier: 00880304517448
• UDI-Public: (01)00880304517448(17)261107(10)3880872
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2023

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: Lay User/Patient
• Device Catalogue Number: 51-149070
• Device Lot Number: 3880872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Patient Sex: Unknown