MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING; PROSTHESIS, HIP

Catalog Number 00625006540

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/07/2020

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 mdr will be submitted.Report source: (b)(6).

Event Description

It was reported that during a hip surgery, the screw component fractured in half during implantation.A portion of the screw was able to be extracted from the operative site, the remainder of the screw was left in acetabular shell component.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: d4; e1; e2, e3; g4; h2; h3; h6.D4: (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause is unable to be determined as the necessary information to adequately investigate the reported event was not provided 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 portion of the hex head of a trilogy bone screw was returned.Visual evaluation identified the following: there was damage on the hex feature and outside the spherical radius.No other damages were noted.Sem analysis revealed the following: trilogy bone screw sample analyzed by sem showed its hex head suspected to have fractured due to bending overload.Bone screw fracture surface showed crack initiation and exit areas.Sheared ductile overload dimples were identified throughout the surface.Evaluation of the returned product does not change the final conclusions of previous investigation.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 additional information on the reported event.

• Brand Name: BONE SCREW SELF-TAPPING
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 10017218
• MDR Text Key: 189744433
• Report Number: 0002648920-2020-00243
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00625006540
• Device Lot Number: 64267564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other