MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT 12/14 TAPER; PROSTHESIS, HIP

Catalog Number	00801803602
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00428.D10: cat #: 00784800200 / modular neck k 12/14 neck taper use with +0 heads only / lot #: 63239625.Proposed component code: mechanical (g04)- head.Visual examination of the returned product identified signs of being implanted worn / foreign material for both devices.The head and neck were submitted for further analysis.Analysis determined a consensus modified goldberg score of 3.A score of 3 corresponds to ¿fretting on >30% of the surface and/or aggressive local corrosion attack with corrosion debris for the head taper and neck trunnion.A consensus modified goldberg score of 2 was assigned to the female neck taper.A score of 2 corresponds to ¿fretting on >10% of the surface and/or corrosion damage to one or more small areas." medical records were provided and reviewed by a health care professional.Review of the available records identified the following: a revision was performed approximately four years post implantation due to pain, tendinitis, and elevated metal ions.During the revision, wear was found around the trunnion and tendons around the trochanter needed repair.The head, neck, and liner were exchanged with no complications noted.The complaint is confirmed based on the evaluation of the returned device and medical records.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause is 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 that a patient underwent a right hip revision approximately four years post implantation due to pain, tendinitis, and elevated cobalt and chromium levels.During the revision, trunnion wear was noted.Additionally, the greater trochanter had a partial under-surface detachment of the abductor tendon with moderate degeneration which included the gluteus medius and minimus.The well-fixed shell and stem were left intact, and all the other components were removed and replaced without complications.

• Brand Name: FEMORAL HEAD STERILE PRODUCT 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18484977
• Report Number: 0002648920-2024-00014
• Device Sequence Number: 16849144
• Product Code: LPH
• UDI-Device Identifier: 00889024144729
• UDI-Public: (01)00889024144729(17)280630(10)64082926
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2024

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 Catalogue Number: 00801803602
• Device Lot Number: 64082926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2023
• 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: 02/07/2023
• Initial Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female