MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FREEDOM ALL POLY CUP 62MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Extraskeletal ossification (1428)
Date of Event	07/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: 802403601 3036377 zb 12/14 cocr frdm 36mm x -6; 01.06010.305 3026493 avenir stem lat cemented 5.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device was discarded.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 patient underwent initial hip arthroplasty on unknown date.Subsequently, the patient was revised due to unknown reason.X-ray review shows acetabular implant is abnormally vertical in position.There is heterotopic ossification laterally and a metallic density overlying the acetabulum.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.This will be reported under mfr number 0001822565 - 2021 - 03315.
Event or Problem Description
Upon reassessment of the reported event, it was determined to be not reportable.This will be reported under mfr number 0001822565 - 2021 - 03315.

• Brand Name: FREEDOM ALL POLY CUP 62MM
• Common Device Name: PROSTHESIS, 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: 12267021
• Report Number: 0001825034-2021-02286
• Device Sequence Number: 19912885
• Product Code: KWZ
• UDI-Device Identifier: 00880304203655
• UDI-Public: (01)00880304203655(17)241122(10)765490
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K030047
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/22/2024
• Device Model Number: N/A
• Device Catalogue Number: 11-107128
• Device Lot Number: 765490
• 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: 07/08/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2019
• 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