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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104)
Date of Event	11/16/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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.
Event or Problem 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.
Additional 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.

• Brand Name: NEUTRAL LINER 36 MM I.D. SIZE II FOR USE WITH 52 MM O.D. SIZE II SHELL
• Common Device Name: 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
• Report Number: 0002648920-2020-00515
• Device Sequence Number: 11635256
• Product Code: JDI
• UDI-Device Identifier: 00889024154971
• UDI-Public: (01)00889024154971
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• 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 Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 12/07/2020; 04/07/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 12/15/2020; 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 49