MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Material Erosion (1214); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994); Joint Dislocation (2374); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unequal Limb Length (4534); Joint effusion (4849)
Date of Event	12/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00206; 0001822565-2024-00207.D10: cat# 00625006535, lot# 64001146 ,bone scr 6.5x35 self-tap; cat# 00875705401, lot# 64009913, 54mm o.D.Size jj porous uncemented with cluster holes shell use with jj liners.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.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 underwent a revision procedure approximately 5 years post implantation due to the development of pain, limb length discrepancy, instability with recurrent dislocations, and metallosis.During the procedure large gray-black synovial effusion, extensive osteolysis and necrotic lesion of r hip soft tissue with complete loss of hip abductor attachments on proximal femur noted.There was extensive debridement of r hip pseudotumor.Gross black debris around the femoral trunnion, the patient underwent revision, the head and liner components were exchanged without complications.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: g3; h2; h3; h6.Proposed component code: mechanical (g04)- head.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 were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed.The patient presented with pain, dislocations, instability, leg length discrepancy, and metallosis.A revision was performed with osteolysis and pseudotumor noted.Black debris was noted on the trunnion.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right total hip arthroplasty without hardware failure or loosening.Patient body habitus does limit evaluation significantly.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 for trends.

• Brand Name: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• 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: 18562108
• Report Number: 0002648920-2024-00019
• Device Sequence Number: 8182864
• Product Code: LPH
• UDI-Device Identifier: 00889024144736
• UDI-Public: (01)00889024144736(17)270630(10)63706950
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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 Model Number: N/A
• Device Catalogue Number: 00801803603
• Device Lot Number: 63706950
• 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: 12/29/2023
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 95 KG