MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM I.D. SIZE GG ELEVATED RIM LINER; PROSTHESIS, HIP

Catalog Number	00875200832
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Synovitis (2094); Joint Dislocation (2374); Metal Related Pathology (4530); Aseptic loosening (4883); Periprosthetic fracture (4902)
Date of Event	07/14/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a left hip revision approximately 5-months post implantation due to dislocation and noted the patient has been falling due to unknown cause.During the revision it was noted the acetabulum was loose, synovitis, screw fractures and significant damage to the bone structures of the pelvis with the entire posterior-superior roof is virtually absent and fragmented.The shell, liner, head, taper adapter, plate, screws, and zimmer frame are exchanged with competitor acetabular construct and allograft.It was confirmed that no further information could be provided.
Additional Manufacturer Narrative
(b)(4).D10: unknown cup.Unknown screws x 7.Cer bioloxd option hd 32mm.Item: 650-1056.Lot: 007000.G2: foreign ¿ canada.The customer indicated that the product location is unknown; therefore, it will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was confirmed that no further information could be provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; h4; h6; h10 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient has a history of revisions, with this one taking place in (b)(6) of 2017.The patient dislocated again and it was fond the cup was loose from several falls.During the revision, it was found the acetabular bone is fragmented and damaged.The cup was loose and the screws were found to be broken.Inflammatory fluid was noted along with synovitis.The ceramic head was found to be mobilized and rubbing, with corrosion debris noted in the joint.The head, cup, bearing, and screws were explanted and replaced.A definitive root cause cannot 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 trends.

• Brand Name: 32MM I.D. SIZE GG ELEVATED RIM LINER
• 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: 23879535
• Report Number: 0001822565-2025-04762
• Device Sequence Number: 21245186
• Product Code: JDI
• UDI-Device Identifier: 00889024149670
• UDI-Public: (01)00889024149670(17)201031(10)63203144
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 00875200832
• Device Lot Number: 63203144
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2015
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female