MAUDE Adverse Event Report: ZIMMER BIOMET, INC. XLPE 10 DEG POLY LINER 56X32; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Unequal Limb Length (4534)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00786401300 tm prim fem st 13mm 63172379.00620205620 tm acet shell 56mm multi 62658917.00625006525 bone scr 6.5x25 self-tap 53165860.00625006530 trilogy bone scr 6.5x30 63160168.00877503202 biolox® delta, ceramic femoral head, m, 32/0, taper 12/14 2794384.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 that the patient states left hip were performed at (b)(6) medical center ((b)(6)).Right hip (stryker) was performed.Patients have had no problems with the right hip but have had pain and problems with the left hip since initial implantation.Patient reports a leg length discrepancy of 1".Patient provided the attached x-ray and states he will be sending medical records in the mail.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.
Event or Problem Description
It was reported that the patient called in with complaints of leg discrepancy, pain and range of motion issues for the past nine (9) years.Patient had a left hip implanted nearly ten (10) years ago and states the doctor has dismissed the claims made.Patient wants confirmation that the implant is adequate.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11 the reported event was able to be confirmed.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 and radiographs were provided and reviewed by a health care professional and a radiologist.The review of the initial surgery report identified a posterolateral approach of a tha performed with no complications, excellent fit and stability with full rom testing.Patient was discharged stable pod 2 with home pt, posterior hip precautions.Review of the radiologist's case report identified that the teardrop-top to lesser trochanter distance is greater on the left compared with the right, which could result in a leg length discrepancy (left longer than right).In addition, the left hip acetabular cup shows lateral overhang.Possible acetabular cup malpositioning or sizing concern was identified as a contributing factor to the event.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information.

• Brand Name: XLPE 10 DEG POLY LINER 56X32
• Common Device Name: PROSTHESIS, HIPS
• 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: 23569214
• Report Number: 0001822565-2025-04167
• Device Sequence Number: 10172655
• Product Code: LPH
• UDI-Device Identifier: 00889024667570
• UDI-Public: (01)00889024667570(17)200229(10)62945897
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K990135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2026

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: 02/29/2020
• Device Model Number: N/A
• Device Catalogue Number: 00631005632
• Device Lot Number: 62945897
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 11/12/2025; 04/24/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/09/2025; 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2015
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 86 KG