MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISCOVERY XS CONDYLE PROVISIONAL MALE/FEMALE; TEMPLATE

Model Number N/A

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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 -04590, 0001825034 -2018 -04655.

Event Description

It was reported that during a revision elbow arthroplasty, following trailing of the components, the surgeon tried to remove a lock screw with a driver but the screw did not release despite trying repeatedly.Eventually, the ulnar trial and humeral trial were forcibly pulled in greater flexion position, which resulted in the patient's bone fracturing.The fracture was fixed with a wire and the procedure was successfully completed.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of product returned.Per visual inspection, the product is at least 8 years old and show severe signs of wear.It is confirmed that the one screw that is installed does not come out of the instrument.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A summary of the investigation has been sent to the complainant.Investigation and root cause remained unchanged.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: DISCOVERY XS CONDYLE PROVISIONAL MALE/FEMALE
• Type of Device: TEMPLATE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7780976
• MDR Text Key: 117134059
• Report Number: 0001825034-2018-04589
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2019

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 Model Number: N/A
• Device Catalogue Number: 414897
• Device Lot Number: 116310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/18/2018
• Initial Date FDA Received: 08/14/2018
• Supplement Dates Manufacturer Received: 09/12/2018; 11/05/2019
• Supplement Dates FDA Received: 09/26/2018; 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 414806,DISCOVERY PROV LOCK SCREW, UNKNOWN; 414845,DISC 3.5X124MM RIGHT HUMTRIAL, UNKNOWN; 414885,DISC 2.5X84MM RIGHT ULNA TRIAL,836410
• Patient Outcome(s): Required Intervention