MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCR 6.5X40 SELF-TAP; PROSTHESIS, HIP

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown acetabular shell, pn unknown, ln unknown.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a hip arthroplasty, the screw head passed through the cup.Screw was removed.Attempts have been made and additional information on the reported event is unavailable at this time.No further information is available.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The screw was returned for evaluation.As returned, damage was observed on the head diameter and spherical diameter.The head diameter, major thread diameter, and overall length were determined to be conforming to print specifications.Dhr was reviewed and no discrepancies were found.A definitive root cause cannot be determined with the information 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.

• Brand Name: BONE SCR 6.5X40 SELF-TAP
• 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: 8544966
• MDR Text Key: 142922586
• Report Number: 0002648920-2019-00305
• 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,health pr
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

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: 00625006540
• Device Lot Number: 64202382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 06/03/2019
• Supplement Dates FDA Received: 06/05/2019
• 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