MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 10 DEGREE FACE ANGLE 28MM; PROSTHESIS, HIP

Catalog Number	00711004828
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a hip revision approximately one week post implantation due to a dislocation.The liner was removed and replaced.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).G2: australia 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.
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues.Impressions: right total hip arthroplasty with superior and likely posterior dislocation of the femoral head.Extensive hetero topic ossification along the right hip.Question prior right acetabular reconstruction.The complaint is confirmed based on the evaluation of the provided medical records.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot be determined, however this is considered off label per the provided instructions under compatibility it states "do not use zimmer biomet uhmwpe acetabular cups and liners with components of any other manufacturer unless authorized by zimmer biomet.To determine whether these devices have been authorized for use in a proposed combination, please contact your sales representative or visit the zimmer biomet electronic labeling service (elabeling) website: http://labeling.Zimmerbiomet.Com." its unknown if this off label caused or contributed to the reported event.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 additional event information to report at this time.

• Brand Name: 10 DEGREE FACE ANGLE 28MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19828397
• Report Number: 0001822565-2024-02456
• Device Sequence Number: 18309088
• Product Code: JDI
• UDI-Device Identifier: 00889024129665
• UDI-Public: (01)00889024129665(17)250430(10)64655901
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K051516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 11/11/2024

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: 04/30/2025
• Device Catalogue Number: 00711004828
• Device Lot Number: 64655901
• 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: 07/02/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK DEPUY HEAD.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male