MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM; PROSTESIS, HIP

Catalog Number 00771301100

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

Patient Problems Pain (1994); Scar Tissue (2060); Synovitis (2094); Tissue Damage (2104)

Event Date 04/20/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device location is unknown.The investigation is in process.Once the investigation is complete, a follow ¿up mdr will be submitted.Concomitant medical products: item #00771301100/ femoral stem/ lot # 61569688, item# 00784801400/ modular neck/ lot # unknown, item# 00877502802/ biolox head / lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 05469.

Event Description

It was reported that patient underwent left hip revision surgery 5 years post implantation due to scar tissue, tissue damage, synovitis.During revision solidly ingrown femoral component was discovered.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.D11 - concomitant medical products: unknown competitor cup.Unknown competitor liner.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of op notes indicated patient was revised due to pain.Scar tissue, tissue damage, synovitis, and a solidly ingrown femoral component were encountered during the revision.The surgeon had difficulty dislocating zimmer/stryker hybrid femoral/acetabular liner components.Root cause was unable to 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 Description

It was reported that patient underwent left hip revision surgery 5 years post implantation due to scar tissue, tissue damage, synovitis, and pain.During revision solidly ingrown femoral component was discovered.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: FEMORAL STEM
• Type of Device: PROSTESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9526993
• MDR Text Key: 178542135
• Report Number: 0001822565-2019-05466
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K063251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2020

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 Expiration Date: 08/31/2020
• Device Catalogue Number: 00771301100
• Device Lot Number: 61569688
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 04/13/2020
• Supplement Dates FDA Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention