MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOM 28MM RNGLOC LNR HWALL 25; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	11-105905
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Peripheral Nervous Injury (4414)
Date of Event	03/31/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) d10: cat# 103535 lot# 405560 ti low profile screw 6.5x40mm cat# 103535 lot# 402580 ti low profile screw 6.5x40mm cat# 103535 lot# 155860 ti low profile screw 6.5x40mm 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.
Event or Problem Description
It was reported the patient underwent an initial left total hip arthroplasty followed by multiple revisions due to pain, metallosis, osteolysis, and recurrent dislocations; the patient developed post-operative foot drop after the second revision, and all implants except the stem were revised approximately six weeks later.The patient was first revised approximately seven years post-implantation due to pain, metallosis, and osteolysis.Approximately two years later, the patient underwent a second revision for recurrent posterior dislocations; intra-operatively, two fractured acetabular screws were identified and the cup was found in a retroverted position.Immediately following the second revision, the patient developed foot drop due to a partial nerve injury with associated weakness of dorsiflexion.Approximately one month post-operatively, the patient presented with recurrent anterior dislocations and underwent a third revision approximately six weeks after the second revision, during which all implants except the stem were revised without complication.Attempts have been made and no further information has been provided.

• Brand Name: ARCOM 28MM RNGLOC LNR HWALL 25
• 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: 25361696
• Report Number: 0001825034-2026-01562
• Device Sequence Number: 10679626
• Product Code: LPH
• UDI-Device Identifier: 00880304202375
• UDI-Public: (01)00880304202375(17)180228(10)794010
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K023357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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: 02/28/2018
• Device Catalogue Number: 11-105905
• Device Lot Number: 794010
• 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: 02/01/2013
• 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