MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. VERSYS HIP SYSTEM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Corroded (1131); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); Necrosis (1971); Joint Dislocation (2374); Osteolysis (2377); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
Date of Event	10/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 636000053; lot# 63028789.Hemispherical porous shell with sealed screwholes 53 mm.The product has been received by zimmer biomet and 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 approximately six years post-implantation, the patient underwent a right hip revision due to instability, dislocations, and elevated metal ions.During the surgery, there was metal debris noted along femoral neck, head, and trunnion which is intact with only minor crepitus erosion; extensive soft tissue and abductor mechanism loss with metallosis; polyethylene wear and impingement posterior; hip was found dislocated; and osteolysis of the greater trochanter.The head, shell, and acetabular liner were exchanged without complications.The stem remained implanted.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; h6.The following sections were corrected: d1.H6: proposed component code: mechanical g(04) head.Visual examination of the returned product identified outer spherical surface shows scratches and scuffs.Taper hole shows dark foreign debris and metal wear in the hole bottom and taper walls.No other damage was noted.Stem and insert were not returned for evaluation.The head was submitted for further analysis.Analysis determined a consensus modified goldberg score of 3.A score of 3 corresponds to ¿fretting on >30% of the surface and/or aggressive local corrosion attack with corrosion debris¿ review of the device history record identified no deviations or anomalies during manufacturing for the head.Medical records were provided and review identified the following: an initial right tha was performed.The patient experienced recurrent dislocations and instability, as well as elevated cobalt levels.A revision was performed where tissue damage, metallosis, poly wear and impingement, and necrotic tissue was found.The hip was also found dislocated upon entering the joint.Metal debris was noted around the femoral neck, head, and trunnion, but the stem was well intact.Additionally, there was osteolysis of the greater trochanter and around the acetabular component.The shell, liner, and head were explanted and new zimmer products were placed, noting excellent rom and stability, and musculature was repaired.Radiographs were provided and assessed but were not sent to mmi as images are post op procedure and will not enhance the investigation.A definitive root cause cannot be determined.This complaint was confirmed based on the returned device and medical records.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 for trends.

• Brand Name: VERSYS HIP SYSTEM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19645917
• Report Number: 0002648920-2024-00213
• Device Sequence Number: 6586729
• Product Code: LPH
• UDI-Device Identifier: 00889024144668
• UDI-Public: (01)00889024144668(17)250731(10)63135580
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 11/25/2024

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: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 00801803201
• Device Lot Number: 63135580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2024
• 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: 03/01/2022
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2015
• 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: Hospitalization; Required Intervention
• Patient Sex: Female