MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 54MM O.D. SIZE JJ POROUS W CLUSTER HOLES SHELL; PROSTHESIS, HIP

Catalog Number	00875705401
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2023-00236, 0002648920-2023-00237, 0002648920-2023-00238.D10: cat #: 00877503601 / biolox⮠delta, ceramic femoral head, s, 㸠36/-3.5, taper 12/14 / lot #: 2651987.Cat #: 00877501136 / biolox⮠delta ceramic taper liner, size jj / 36 i.D.For use with 54 mm o.D.Size jj shell / lot #: 2727208.Cat #: 00811400100 / femoral stem 12/14 neck taper standard offset size 1 130 mm stem length / lot #: 62586389.Cat #: 00625006530 / bone screw self-tapping 6.5 mm dia.30 mm length / lot #: 62619015.Cat #: 00625006520 / bone screw self-tapping 6.5 mm dia.20 mm length / lot #: 62619024.G2: scotland/united kingdom.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 approximately nine years post implantation, patient is presenting with pain and a pseudotumor was found on an x-ray.To date, no revision has been scheduled.Attempts have been made and no further information is available.
Event or Problem Description
It was reported a patient underwent a hip revision approximately nine years post implantation due to pain and a pseudotumor.During the procedure, inflammation and implant wear were noted.The shell was well fixed and remains implanted.The stem, liner, and head were removed and replaced.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.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).Upon receiving additional information of the reported event, it was determined to be not reportable as this product was not involved in the event.The initial report should be voided.
Event or Problem Description
Upon receiving additional information of the reported event, it was determined to be not reportable as this product was not involved in the event.The initial report should be voided.

• Brand Name: 54MM O.D. SIZE JJ POROUS W CLUSTER HOLES SHELL
• 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: 17868203
• Report Number: 0001822565-2023-02706
• Device Sequence Number: 7041963
• Product Code: JDI
• UDI-Device Identifier: 00889024151406
• UDI-Public: (01)00889024151406(17)240128(10)62590993
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 01/29/2024

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: 01/28/2024
• Device Catalogue Number: 00875705401
• Device Lot Number: 62590993
• 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: 09/12/2023
• Supplement Date Received by Manufacturer: 11/28/2023; 01/17/2024
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 12/21/2023; 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2014
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown