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

Model Number	N/A
Medical Device Problem Codes	Corroded (1131); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fatigue (1849); Hearing Impairment (1881); Failure of Implant (1924); Pain (1994); Tinnitus (2103); Metal Related Pathology (4530); High metal ion levels (4847)
Date of Event	01/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: unknown- stem taper standard neck size 12.5 ml-unknown, 00630505832- liner standard 32 mm i.D.For use with 58 mm o.D.Shell- 62301828, unknown-unknown shell-unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2022 - 00402.Customer has indicated that the product will not be returned to zimmer biomet for investigation, not returned by patient.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 patient underwent a left hip revision due to metallosis during the procedure the head and liner were revised without complication.No allegations against liner, surgeon said the poly looked good.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.Reported event was unable to be confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record for the head identified no deviations or anomalies during manufacturing related to the reported event.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.
Event or Problem Description
No additional information on the reported event.
Event or Problem Description
It was reported that a patient underwent a left hip revision approximately 9 years post implantation due to metal related pathology.During the procedure, the head and liner were repalaced without complications.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d6; g3.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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a2; b4; b5; b7; g3; h6.Proposed component code: mechanical (g04)- 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, with no complications noted.A revision occurred due to elevated metal ions and pain.During the revision corrosion was noted on the base of the trunnion and femoral head.The head and liner were explanted and replaced with no complications noted.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
It was reported a patient underwent a left hip revision approximately nine years post implantation due to a concern for systemic symptoms of metallosis, pain and elevated metal ion levels.During the procedure, corrosion to the trunnion and slightly to the femoral head was noted as well.The head and liner were exchanged without and further apparent complications.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified outer spherical surface and flat area around the taper hole show scratches and dings.Taper hole shows dark foreign debris.No other damage was noted.The stem was not returned and pictures were not provided of the stem.The head was submitted for further analysis.Analysis determined a consensus modified goldberg score of 2.A score of 2 corresponds to ¿fretting on >10% of the surface and/or corrosion damage to one or more small areas¿ the complaint was confirmed based on the provided medical records and returned head with dark foreign debris.Root cause remains 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: PROSTHESIS, 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13508000
• Report Number: 0002648920-2022-00033
• Device Sequence Number: 4228106
• Product Code: LPH
• UDI-Device Identifier: 00889024144675
• UDI-Public: (01)00889024144675(17)230331(10)62326128
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• 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,Followup,Followup,Followup
• Report Date (Section B): 04/10/2024

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: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00801803202
• Device Lot Number: 62326128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/20/2022
• Supplement Date Received by Manufacturer: 02/23/2022; 03/27/2023; 06/15/2023; 04/05/2024
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 02/28/2022; 03/31/2023; 07/07/2023; 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2013
• 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: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male