MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC LATERAL POROUS FEMORAL; PROSTHESIS, HIP

Catalog Number 103808

Device Problem Mechanical Jam (2983)

Patient Problem Pain (1994)

Event Date 01/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item # 11-105903/ arcom ringloc liner / lot # 579380, item # 12-104152/ shell /lot # 235210, item # 163660/ cocr mod hd /lot # 221520, item # 631034/ redi-flow reg sys /lot # 200901, item # 103530/ ti low profile screw /lot # 778480, item # 103534/ ti low profile screw /lot # 304674.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2020 -00593, 0001825034 -2020 - 00594.

Event Description

It was reported the patient underwent a hip revision procedure 19 years post-implantation due to pain.During the revision procedure, the surgeon indicated that the trunnion of the stem was impinging against the hi-wall lip of the polyethylene liner when patient was in abduction.Further, the liner was found to be worn.The liner and head were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.Radiographs identified left total hip arthroplasty with polyethylene wear of the acetabular cup.The liner wear was confirmed.However, the impingement was not confirmed.Dhr was reviewed and no discrepancies relevant to the reported event were found.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.

• Brand Name: TAPERLOC LATERAL POROUS FEMORAL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9690155
• MDR Text Key: 178536021
• Report Number: 0001825034-2020-00635
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K921301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2010
• Device Catalogue Number: 103808
• Device Lot Number: 761580
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR