MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TLOC 133 OFFSET INSERTER ASSY; INSTRUMENT, HIP

Catalog Number 51-222224

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed a follow-up.

Event Description

It was reported that during an initial hip procedure the tip of the stem impactor was found to be broken off.Examination of post op x-rays show the tip inside the stem implant.No revision surgery has been reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

One tloc 133 offset inserter assy was returned and evaluated.Upon visual inspection the device had fractured at the tip.The fractured portion of the device was not returned and there were impact marks on the strike plate.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not 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: TLOC 133 OFFSET INSERTER ASSY
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11055650
• MDR Text Key: 223147196
• Report Number: 0001825034-2020-04410
• Device Sequence Number: 1
• Product Code: OQG
• Combination Product (y/n): N
• PMA/PMN Number: K120030
• 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: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 51-222224
• Device Lot Number: 064417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR