MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXACT 1/4-28 THRD STM/RSP EXT; INSTRUMENT, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: item # unk biomet head item name: unk.Item # unk echo stem item name: unk.The product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient was revised due to pain and dislocation of the bipolar head from patient¿s anatomy.During revision, the adaptor broke inside the stem being extracted, none of the broken pieces fell into the patient.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.

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.The device was returned and evaluated against the complaint.Visual inspection confirmed the shaft of the extension to have fractured through the threaded tip.The fractured tip was not returned.The fractured surface is discolored by reddish-brown debris.The shaft exhibits scuffs and wear marks consistent with a multiple use instrument.Sem analysis identified the following: fracture surface analysis performed by sem on the stem extractor sample showed that it is suspected to have fractured due to bending overload.Stem extractor fracture surface revealed river lines which showed the direction of crack progression and indications of suspected crack initiation and exit areas.Quasi-cleavage mode of overload fracture identified throughout the extractor fracture surface.Shear lip identified near the edge of the fracture, which suspected to be the crack exit area.Eds semi-quantitative elemental analysis of the threaded pin showed that it was consistent with 420 stainless steel.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot 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: EXACT 1/4-28 THRD STM/RSP EXT
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10845500
• MDR Text Key: 216643693
• Report Number: 0001825034-2020-04124
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: X31-400001
• Device Lot Number: ZB110901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1