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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ossification (1428)

Event Date 04/22/2021

Event Type  Injury  

Event 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.

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.

Manufacturer Narrative

Upon reassessment of the reported event, it was identified that this device did not cause or contribute to the reported event.

Event 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
• Type of Device: 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
• MDR Text Key: 280684272
• Report Number: 0002648920-2021-00402
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00889024362147
• UDI-Public: (01)00889024362147(17)280331(10)63954127
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 02/28/2022
• Supplement Dates FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 97 KG