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

Model Number	N/A
Medical Device Problem Codes	Corroded (1131); Material Erosion (1214)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Scar Tissue (2060); Metal Related Pathology (4530); High metal ion levels (4847)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Initial right total hip arthroplasty performed due to a fall resulting in a displaced right transcervical femoral neck fracture.Subsequently, the patient was revised due to pain and elevated metal ion level.During the revision a blackened line was noted around the interface between the head and the prosthetic neck, consistent with corrosion or trunnionosis.The stem was noted to be well fixed.The liner and head were exchanged without complications.
Additional Manufacturer Narrative
(b)(4).D10: 00-8757-052-01 continuum cluster-hole shell, 52 ii 64004377 00625006530 bone screw self-tapping 6.5 mm dia.30 mm length 64076424 00625006530 bone screw self-tapping 6.5 mm dia.30 mm length 64145412 00-8751-010-36 liner neutral highly crosslinked continuum 36x52 64052273 this follow-up report is being submitted to relay additional and/or corrected information.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: g3, g6, h2, h3, h6 proposed code: mechanical (g04) ¿ head no product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pre-op ct and xray show well-placed, well-fixed implants.Patient has had persistent pain around her hip.Somewhat mixed inflammatory markers, slightly elevated cobalt with normal chromium.General anesthesia, ebl 100ml and previous incision utilized.Scar tissue was released.Modest amount of milky fluid was noted, sampled, and sent for culture.Blackened line was noted around the interface between the head and the prosthetic neck, consistent with corrosion or trunnionosis.Stem was well fixed.Liner was removed, there was no evidence of poly wear.Tissue deep to the liner overlying the component was noted and sent for culture.Final xray demonstrated implants in good position.Patient to recovery in stable condition.No intraoperative complications noted.A definitive root cause cannot be determined.Based on the medical records provided, the complaint is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• Common Device Name: PROSTHESIS, HIPS
• 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: 19608906
• Report Number: 0002648920-2024-00203
• Device Sequence Number: 12783615
• Product Code: LPH
• UDI-Device Identifier: 00889024144712
• UDI-Public: (01)00889024144712(17)280731(10)64103371
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K061786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00801803601
• Device Lot Number: 64103371
• 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: 06/04/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2018
• 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 H11 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female