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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	08/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: item number 650-1066 item name cer opt type 1 tpr sleve0mm lot # 3062944; item number 650-1056 item name cer bioloxd option hd32mm lot #unk; item number unk cup item name unk cup lot # unk.The device will not be returned for analysis as implant was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported a patient underwent an initial hip arthroplasty on an unknown date.Subsequently, the patient was revised approximately one month ago due to peri prosthetic fracture of the femur after a fall.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.  review of the device history records identified no (related) deviations or anomalies during manufacturing no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.It was reported patient fell and fractured the femur.However, without additional information a definitive root cause could not be determined.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
No further event information available at the time of this report.

• Brand Name: TPRLC 133 FP TYPE1 PPS SO 6.0
• Common Device Name: PROSTHETIC, 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: 12447720
• Report Number: 0001825034-2021-02607
• Device Sequence Number: 3651953
• Product Code: KWA
• UDI-Device Identifier: 00880304498174
• UDI-Public: (01)00880304498174(17)281129(10)6436014
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K103755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 51-100060
• Device Lot Number: 6436014
• 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: 08/24/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female