MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Necrosis (1971); Swelling (2091); Osteolysis (2377); No Information (3190)

Event Date 07/06/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis as it remains implanted; 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: 0002648920-2021-00010.

Event Description

It was reported by patients¿ legal counsel that the patient underwent a right hip revision procedure approximately three years and five months post initial implantation.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: zimmer m/l taper femoral stem (00-7711-007-00, 60777592).Zimmer versys femoral head -3.5 (00-8018-032-01, 60823987).Zimmer tm modular acetabular shell (00-6202-052-22, 50807373).Zimmer trilogy acetabular liner (00-6310-050-32, 60513416).Zimmer bone screw (00-6250-065-30, 60821841).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00306, 0001822565-2021-00167, 0002648920-2021-00010.

Event Description

It was reported the patient underwent right total hip arthroplasty.Subsequently a revision was performed approximately 3 years later due to pain, elevated metal ions, osteolysis and corrosion.The femoral head and liner were revised.No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D11: zimmer m/l taper femoral stem (00-7711-007-00, 60777592); zimmer versys femoral head -3.5 (00-8018-032-01, 60823987); zimmer tm modular acetabular shell (00-6202-052-22, 60807373); zimmer trilogy acetabular liner (00-6310-050-32, 60513416); zimmer bone screw (00-6250-065-30, 60821841).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Operative notes were provided and reviewed by a healthcare professional.Patient was revised due to pain, elevated metalions, osteolysis and corrosion.Right hip pain, with effusion and elevated wbc, high crp, sed rate.Right hip exploration, biopsies, acetabulum system, liner & head exchange.Found small amount of edema in capsular tissue.No evidence of loosening.Trochanteric lesion was found, brownish gelatinous material removed.Femoral head removed, black debris around trunnion, no evidence of motion between head and trunnion.Minimal wear of poly.Osteolysis beneath cup, but minimal amount; white tissue was removed from screw holes debridement of acetabulum.Pathology found fibrous tissue, necrotic and debris, some specimen¿s positive for acute inflammation.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00306; 0001822565-2021-00167; 0002648920-2021-00010; 0002648920-2021-00125.

Event Description

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

• Brand Name: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11171869
• MDR Text Key: 226858718
• Report Number: 0001822565-2021-00167
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K192660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 00771100700
• Device Lot Number: 60777592
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2021
• 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: 96