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

Model Number	N/A
Medical Device Problem Codes	Material Erosion (1214); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Osteopenia/ Osteoporosis (2651); Metal Related Pathology (4530)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00630506036 liner standard 3.5 mm offset 36 mm i.D.For use with 60 mm o.D.Shell lot number 62827778.00784301306 femoral stem beaded fullcoat 12/14 neck taper std.Body std.Offset size 13 13 mm distal dia.160 mm length lot number 62928933.00620006022 shell porous with cluster holes 60 mm o.D.Lot number 63021872.H6: component code: mechanical (g04) - head.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted h3 other text : device location is unknown.
Event or Problem Description
It was reported that approximately 6 years and 4 months post implantation, the patient underwent a revision procedure due to pain, instability with recurrent dislocations, and elevated cobalt and chromium levels.During the revision, dark blackish fluid from the joint was sent for culture, extensive metallosis was debrided from the trunnion, femoral head and acetabular tissue and bone loss was noted in the posterior acetabular wall.The acetabular component noted to be somewhat retroverted.The femoral stem was left intact, and all other components were revised without complication.There is no additional information available at the time of this report.
Event or Problem Description
There is no update to the prior event description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history identified additional similar complaints for the head.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha was performed on (b)(6) 2015 with no complications noted.The patient reported multiple dislocations, as well as elevated metal ions and pain.A revision occurred on (b)(6) 2021, where metallosis was identified within the joint.Bone loss noted posteriorly to the cup.All components were explanted except the stem, with new zb products placed.Root cause unchanged.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: PROSTHETIC, 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: 17143468
• Report Number: 0002648920-2023-00118
• Device Sequence Number: 11236508
• Product Code: LPH
• UDI-Device Identifier: 00889024144736
• UDI-Public: (01)00889024144736(17)250531(10)63079301
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

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: Lay User/Patient
• Device Expiration Date: 05/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 00801803603
• Device Lot Number: 63079301
• 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: 12/16/2022
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2015
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male