MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE; PROSTHESIS HIP

Catalog Number	00801803602
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	05/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Visual examination of the provided pictures identified slight wear on the surfaces of the head and neck.Products covered in bio-debris.No further evaluation can be made from the pictures provided.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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.Concomitant medical products: item # 00784803201/ modular neck g2 12/14 neck taper / lot # 61576382.Item # 00875705801/ shell with cluster holes/lot # 61499725.Item # 00875201336/ liner elevated rim/lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-01681.
Event or Problem Description
It was reported that patient underwent initial left total hip arthroplasty approximately 11 years ago.Subsequently, the patient was revised due to pain and suspected metallosis.The surgeon removed kinectiv head and neck and found very little signs of wear.As a result, the surgeon decided to remove the acetabular cup for possible loosening.Cup seemed well fixed.No further event information available at the time of this report.

• Brand Name: FEMORAL HEAD STERILE
• 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
• MDR Report Key: 12439431
• Report Number: 0002648920-2021-00253
• Device Sequence Number: 3516667
• Product Code: LPH
• UDI-Device Identifier: 00889024144729
• UDI-Public: (01)00889024144729
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2021

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: 12/31/2020
• Device Catalogue Number: 00801803602
• Device Lot Number: 61687775
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Weight: 96