MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN TAPER STEM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Material Erosion (1214); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteopenia/ Osteoporosis (2651); Metal Related Pathology (4530); Insufficient Information (4580)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No product was returned, or pictures provided; visual and dimensional evaluation could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records and compatibility checks, neither were provided.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00070, 0001822565-2023-00071, 0001822565-2023-00072.
Event or Problem Description
It was reported by the patient's legal counsel that the patient had a versys femoral head and a zimmer m/l taper stem implanted in the left hip.It was reported that the left hip components were later explanted for allegations of unspecified injuries.No additional information.
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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: sections updated b4 b7 d1: femoral stem beaded fullcoat 12/14 neck taper std.Body std.Offset size 13 13 mm distal dia.160 mm length d2: device product code g3 g4: pma/510(k) number g6 h2 h10.Sections corrected: b5 d6b: explant date provided in error h6.
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 there is no additional similar complaints for the stem 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.
Event or Problem Description
There is no update to the prior event description provided.

• Brand Name: UNKNOWN TAPER STEM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): .; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16115797
• Report Number: 0001822565-2023-00067
• Device Sequence Number: 20579691
• Product Code: LPH
• UDI-Device Identifier: 00889024136533
• UDI-Public: (01)00889024136533(17)250430(10)62928933
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 00784301306
• Device Lot Number: 62928933
• 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: 05/22/2023; 08/30/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 06/16/2023; 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2015
• 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
• 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: Hospitalization; Required Intervention; Other
• Patient Age: 67 YR
• Patient Sex: Male