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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Concomitant medical products: catalog number: 110010241, lot number: 6297939, brand name: g7 osseoti46mm ltd b.Catalog number:110024460, lot number: 707400, brand name: g7 dm metal liner 36mm b.Catalog number: 00771301000, lot number: 63958381, brand name: ml taper kinectiv size10.Catalog number: 00784801200, lot number: 63958196, brand name: modular neck size e.Catalog number: 00801802202, lot number: 63904959, brand name: cocr head +0x22mm.Catalog number: 010000991, lot number: 602010, brand name: e1aa brg 36mm id22mm.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.
Event or Problem Description
It was reported that the patient was revised due to hip dislocation and disassociation of the head and bearing approximately 4 years post implantation.Attempts have been made and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, h1, h2, h3, h6, h10 h6: component code: mechanical - g04 head visual examination of the provided pictures identified the bearing/head and stem with the bearing showing damage to the outside radius, it is unknown if that damage was caused invivo or during extraction of the device medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: interval dislocation of the right hip arthroplasty reported event was confirmed by review of x-rays provided.Review of the device history records identified no deviations or anomalies during manufacturing.Root cause could not 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 further event information available at the time of this report.

• Brand Name: FEMORAL HEAD STERILE PRODUCT
• 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: 14291769
• Report Number: 0002648920-2022-00116
• Device Sequence Number: 5283379
• Product Code: LPH
• UDI-Device Identifier: 00889024144538
• UDI-Public: (01)00889024144538(17)310128(10)63904959
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2022

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 Model Number: N/A
• Device Catalogue Number: 00801802202
• Device Lot Number: 63904959
• 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: 04/20/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2018
• 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
• 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
• Patient Sex: Unknown