MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 52E; PROSTHESIS, HIP

Catalog Number	010000663
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: unknown 36mm liner.Unknown head.Unknown taperloc microplasty size 6 stem.Unknown sleeve.The customer indicated that the product remains implanted; 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 reported that the patient has been experiencing right hip issues and pain since his initial implantation.It is now approximately 11 (eleven) years post-surgery.No further details or medical records have been provided.
Event or Problem Description
No additional information available for the reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b6; d1; d2b; d4; d10; g3; g4; h2; h4; h6.D10: g7 neutral e1 liner 36mm e.Item: 010000857.Lot: 3302871.Tprlc 133 mp type1 pps so 11.0.Item: 51-106110.Lot: 3311802.Cer bioloxd option hd 36mm.Item: 650-1057.Lot: 392850.Cer option type 1 tpr sleve -6.Item: 650-1064.Lot: 992340.Once the investigation has been completed, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a5; a6; b5; b6; b7; g3; h2; h3; 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 related to the reported event.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: patient had a right tha previously.Patient has since been having issues and reporting pain in the hip.During the follow-ups the doctor notes he is concerned for metallosis and trunnionosis.Patient had x-rays and blood lab results.Results have no evidence of fracture or dislocation, had good alignment.Lab test results for chromium and cobalt are normal within range.Mri results show no evidence of osseous abnormality or osteolysis.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.
Event or Problem Description
It was reported that the patient has been experiencing right hip issues and pain since his initial implantation.It is now approximately 11 (eleven) years post-surgery.An mri was performed that displayed small chronic bone fragments at the greater trochanter; otherwise, unremarkable without evidence of osseous abnormality or osteolysis.All products remain implanted.Due diligence is complete as multiple attempts were made; however, no further information is available.

• Brand Name: G7 PPS LTD ACET SHELL 52E
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23485636
• Report Number: 0001825034-2025-03490
• Device Sequence Number: 10559129
• Product Code: PBI
• UDI-Device Identifier: 00880304524224
• UDI-Public: (01)00880304524224(10)3360499(17)240725
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/25/2024
• Device Catalogue Number: 010000663
• Device Lot Number: 3360499
• 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: 10/11/2025
• Supplement Date Received by Manufacturer: 11/11/2025; 01/20/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 12/03/2025; 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2014
• 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
• 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; SEE H11
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White