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

Model Number	N/A
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	10/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog number:00771101000 lot number: 61963088 brand name: femoral stem, catalog number:00620205022 lot number: 61977279 brand name: tm modular cup, catalog number:00631005032 lot number: 61970773 brand name: acetabular liner.Multiple reports were submitted along with this report 0002648920-2021-00069, 0001822565-2021-00903.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 was revised due to pain, elevated ion levels, adverse location tissue reaction (altr) and bone loss at the posterior proximal femur approximately 7 years post implantation.During the revision procedure, the surgeon noted corrosion around the trunnion and in the femoral head.The femoral head was removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient was revised due to pain and elevated metal ions.Corrosion was found at the neck head junction on the trunnion, with evidence of altr and loss of all cancellous bone in the posterior proximal femur.Additionally, there was thick, dark bloody fluid in the capsule.Good ingrowth was found and attempts to extract the component were unsuccessful so the implant was not removed.The acetabular component was well ingrown and the polyethylene was in good shape without staining or wear.Only the head was replaced, the stem, liner, and shell were left intact.The head was replaced with a new zimmer biomet device.The pathology report for the gross analysis of the head found synovitis, but was negative for acute inflammation and features of alval were not seen.Patient continues to experience ongoing hip pain.Reported event was confirmed by review of medical records provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided.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
• Common Device Name: HIP, PROSTHESIS
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 11604273
• Report Number: 0002648920-2021-00069
• Device Sequence Number: 4139052
• Product Code: LPH
• UDI-Device Identifier: 00889024144675
• UDI-Public: (01)00889024144675(17)131221(10)61947585
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2021

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: 12/13/2021
• Device Model Number: N/A
• Device Catalogue Number: 00801803202
• Device Lot Number: 61947585
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 08/26/2021
• 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