MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEUTRAL LINER 36 MM I.D. SIZE II FOR USE WITH 52 MM O.D. SIZE II SHELL; PROSTHETIC, HIP

Model Number N/A

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 00877503601 | item name: biolox⮠delta, ceramic femoral head, s, 㸠36/-3.5, taper 12/14 | lot#3013180.It is unknown if the device will be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03994.0001822565 - 2020 - 03995.0001822565 - 2020 - 04005.

Event Description

It was reported a patient had an initial right total hip arthroplasty.Subsequently, the patient was revised approximately 4 months later due to pain, difficulty ambulating, and tissue damage.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported a patient had an initial right total hip arthroplasty.Subsequently, the patient was revised approximately 4 months later due to pain, difficulty ambulating, and tissue damage.There was nothing wrong with the screws themselves, they were just placed in a position that was causing soft tissue irritation and were, therefore, removed.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Additional mdr report was filed for this event, please see associated reports: 0002648920-2020-00526.

Manufacturer Narrative

Upon reassessment of the reported event, the liner was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, the liner was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: NEUTRAL LINER 36 MM I.D. SIZE II FOR USE WITH 52 MM O.D. SIZE II SHELL
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 10946874
• MDR Text Key: 219555777
• Report Number: 0002648920-2020-00515
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00889024154971
• UDI-Public: (01)00889024154971
• Combination Product (y/n): N
• PMA/PMN Number: K200823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2021

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: 00885101036
• Device Lot Number: 64552127
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 12/07/2020; 04/07/2021
• Supplement Dates FDA Received: 12/15/2020; 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 49