MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCR 6.5X30 SELF-TAP; HIP PROSTHESIS

Model Number N/A

Device Problems Positioning Failure (1158); Fracture (1260); Failure to Advance (2524)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: item # 00-8757-052-01 continuum cluster-hole shell, 52 ii lot # 64108383, item # 00-8018-036-02 12/14 cocr femoral head 36mm +0 lot # 63981297, item # 00-7711-009-40 m/l taper 9 ext reduced neck length lot # 63042462, item # 00-8752-010-36 continuum longevity elevated liner, ii 36 x 52 lot # 64166273.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 total hip arthroplasty, upon noticing the head of bone screw was not seating, the surgeon attempted to back it out.The threads got caught on the underside of the shell and would not allow the screw to back out.In attempting to back the screw out, the head of the screw was broken off and the shaft was left in the pelvis.No further patient consequences have been reported.Attempts were made to obtain additional information, however, none was available.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.No product was returned; visual and dimensional evaluations could not be performed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was 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

It was reported that upon noticing the head of screw was not seating.In attempting to back the screw out, the head of the screw was broken off and the shaft was left in the pelvis.No adverse affects other than screw shaft in the pelvis.Attempts were made to obtain additional information; however, none is available.

• Brand Name: BONE SCR 6.5X30 SELF-TAP
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 8398571
• MDR Text Key: 138077237
• Report Number: 0002648920-2019-00131
• Device Sequence Number: 1
• Product Code: MRA
• 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,health profession
• Type of Report: Initial,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• 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: 00625006530
• Device Lot Number: 64263394
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR