MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M/L TAPER G2 NECK - MODULAR NECK; PROSTHESIS, HIP

Catalog Number 00784800200

Device Problems Corroded (1131); Material Erosion (1214)

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

Event Date 01/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: liner standard 3.5 mm cat# 00630505036 lot# 61281052, femoral head cat# 00801803602 lot# 61269403, tm shell cat# 00620205022 lot# 61273459, screw cat# 00625006530 lot# 61277468, stem cat# 00771300700 lot# 61068324.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 medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00047, 0002648920 - 2020 - 00048.

Event Description

It was reported that a patient had an initial left total hip arthroplasty performed.Subsequently, the patient was revised approximately 10 years later due to pain, bursitis, tendon tear, and elevated metal ions.During the revision surgery, no tissue reaction was found but minimal head and neck taper corrosion was noted.The head, neck, liner, and locking ring were replaced without complication, and the torn tendon was repaired.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 following sections were updated/corrected: updated: b4, b5, g4, g7, h2, h3, h6, h10.The event was confirmed with medical records received.Primary op notes were reviewed and no complications were noted.Medical notes were reviewed and identified: cobalt 4.8 (normal :3.9), chromium 3.0 (normal <=5.0) mri results - no evidence for bone resorption/advanced particle disease, small joint effusion with mild distention of the iliopsoas bursa, moderate trochanteric bursitis and moderate to severe gluteus minimus tendinosis (enthesopathy)/ partial tear office visit - bilateral hip injections given, symptoms remain unchanged, pain, fall, additional injection provided at visit without complication, scheduled for revision of head and liner due to altr (later negated in intraop findings), gluteus medius tendinopathy diagnosed on mri.Revision op notes were reviewed and identified the following: no obvious tissue reaction, minimal corrosion at the head and neck junction.Minimal bursitis present.-locking ring stuck in position due to tissue debris, liner removed, new locking ring placed without difficulty, head and neck placed.No further complications 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.

Event Description

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

• Brand Name: M/L TAPER G2 NECK - MODULAR NECK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9653020
• MDR Text Key: 177174390
• Report Number: 0001822565-2020-00402
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 00784800200
• Device Lot Number: 61045351
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 82