MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC MICRO LAT FMRL 11MM; PROSTHESIS HIP

Model Number N/A

Device Problem Flaked (1246)

Patient Problems Host-Tissue Reaction (1297); Osteolysis (2377); Reaction (2414)

Event Date 01/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# us157852 m2a-magnum pf cup 52odx46id lot# 990270, item# 157446 m2a-magnum mod hd sz 46mm lot# 638060, item# 139254 m2a-magnum 42-50mm tpr insrt-3 lot# 965010.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 10603, 0001825034 - 2018 - 10598.

Event Description

It was reported that patient underwent revision 7 years post implantation due to metallosis/osteolysis/hypertrophy.Physician encountered gray-green fluid, clear metallic staining of all synovial surfaces and hypertrophy of the synovium, severe osteolysis, and large cavitary defects filled with metallic stained debris.It was noted after product was returned, a small amount of bio debris is affixed to the stem as well as porous coating peeling off.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.Visual inspection of the cup identified wear on the porous coating and porous coating peeling off.Visual inspection identified damages on the rim of the head and outer diameter of taper adapter likely caused while trying to remove the head and taper from the stem.A small amount of bio debris is affixed to the stem as well as porous coating peeling off.Device history record (dhr) was reviewed and no discrepancies 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: TAPERLOC MICRO LAT FMRL 11MM
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8706834
• MDR Text Key: 148260603
• Report Number: 0001825034-2019-02590
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K062994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/17/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 15-103205
• Device Lot Number: 661240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 07/10/2019
• Supplement Dates FDA Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 42 YR