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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Extraskeletal ossification (1428)
Date of Event	04/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent initial left partial hip arthroplasty.Subsequently the patient was revised to total arthroplasty approximately 3 years later due to pain and arthritic disease progression.During the revision, significant ho was encountered and removed from the posterior capsule.The head was exchanged without complication.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis, as the device was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 03274 and 0002648920 - 2021 - 00403.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was identified that this device did not cause or contribute to the reported event.
Event or Problem Description
Upon reassessment of the reported event, it was identified that this device did not cause or contribute to the reported event.

• Brand Name: ENDO FEMORAL HEAD 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: 12802787
• Report Number: 0002648920-2021-00402
• Device Sequence Number: 4673420
• Product Code: JDI
• UDI-Device Identifier: 00889024362147
• UDI-Public: (01)00889024362147(17)280331(10)63954127
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K955473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00781805100
• Device Lot Number: 63954127
• 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: 10/22/2021
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2018
• 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: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 97 KG