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

Catalog Number	00801803201
Medical Device Problem Codes	Corroded (1131); Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Metal Related Pathology (4530)
Date of Event	07/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item#: 00771100900/ femoral stem / lot #: 61690517.Item #: 00620005622/shell porous /lot #: 61660755.Item #: 00625006525 / bone scr/lot #: 61604354.Item #: 00630505632/liner/lot #: 61604354.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2021 -02131.
Event or Problem Description
It was reported that patient underwent a underwent an initial left total hip arthroplasty on an unknown date subsequently the patient was revised due to adverse local tissue reaction (altr).Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: a4: b5; b7; d6; g2; g3; h2; h3; h6.
Event or Problem Description
It was reported patient underwent left a left hip revision surgery 11 years post implantation due to elevated metal ion levels.During the revision the surgeon noted corrosion and psuedocapsule with capsulotomy performed.The head and liner were replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent a left tha revision.It was noted that the cobalt level was higher than normal, and found blackening of the trunnion along with a pseudocapsule within the joint.The stem, and cup/screws were well fixed, the locking ring moved but was not damaged, and the poly was discolored.A new head and liner was placed with no complications.Root cause remains unchanged.
Event or Problem Description
No further event information available at the time of this report.

• 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
• MDR Report Key: 12258760
• Report Number: 0002648920-2021-00205
• Device Sequence Number: 19554600
• Product Code: LPH
• UDI-Device Identifier: 00889024144668
• UDI-Public: (01)00889024144668(17)210318(10)61751513
• 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: 2011
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/12/2021

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: 03/31/2021
• Device Catalogue Number: 00801803201
• Device Lot Number: 61751513
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 08/03/2021; 09/20/2021; 10/11/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 08/11/2021; 10/05/2021; 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 73