MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPER ADAPTOR REMOVAL TOOL; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Date 12/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).The reported event is confirmed as the photographs showed damage of the threads and the threads were also worn out.The taper adaptor body showed wear and missing component.No products were returned; therefore, the visual and dimensional inspections were not performed.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.The potential field age of the product is approximately 2 years 2 months with unknown frequncy of usage.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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

It was reported that during hip arthroplasty revision, the extractor threads were damaged and stripped and were unable to be assembled with the mating implant.A 60 minute delay was noted, as the well fixed stem had to be removed to successfully complete the procedure.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned device confirmed that the removal threaded shaft was fractured in two pieces and the distal threads of the handle assembly were damage and shows signs of wear and tear.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: TAPER ADAPTOR REMOVAL TOOL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7169970
• MDR Text Key: 96581702
• Report Number: 0001825034-2017-11499
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK082996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 110005232
• Device Lot Number: 679270
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Date Manufacturer Received: 08/21/2018
• 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