MAUDE Adverse Event Report: ZIMMER BIOMET, INC. REGEN/RNGLC+ MULTI 68MM SZ 27; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	PT-106068
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Joint Dislocation (2374); Radiolucent Lines (4848)
Date of Event	02/18/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a second left total hip revision approximately 2 years and 2 months after a prior revision due to recurrent posterior dislocations.The patient previously underwent an initial left total hip arthroplasty, and approximately 7 years post-implantation was revised due to pain, metallosis, and osteolysis.During the second revision, intra-operative findings included lucency of the acetabular cup, two fractured acetabular screws, and the cup positioned in retroversion.All implants except the femoral stem were revised without complication.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat# 11-104113 lot# 085600 mlry-hd por fmrl 13x170mm.G2: foreign - event occurred in canada.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 3500a will be submitted.

• Brand Name: REGEN/RNGLC+ MULTI 68MM SZ 27
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 25361445
• Report Number: 0001825034-2026-01557
• Device Sequence Number: 10654054
• Product Code: LPH
• UDI-Device Identifier: 00887868341977
• UDI-Public: (01)00887868341977(17)220628(10)938300
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K070369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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
• Device Expiration Date: 06/28/2022
• Device Catalogue Number: PT-106068
• Device Lot Number: 938300
• 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: 05/12/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male