MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH; PROSTHESIS, HIP

Model Number N/A

Device Problems Positioning Failure (1158); Misassembled (1398)

Patient Problem No Information (3190)

Event Date 04/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #: unknown, unknown head, lot #: unknown, item #: unknown, unknown stem, lot #: unknown, item #: unknown, unknown liner, lot #: unknown, 110010245 g7 osseoti 4 hole shell 54mm f 6612060.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.The investigation is in process.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: 0001825034-2020-02162.

Event Description

It has been reported patient underwent right hip arthroplasty.The cup migrated and the patient subsequently dislocated less than two weeks later.The patient was then revised the following day.Upon examination, it was determined that the screw passed through the cup fixation hole during the initial implantation.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, g4, h2, h3, h6.Reported event was confirmed by review of radiographs.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Radiographs identified the following : 1.Right total hip arthroplasty with possible penetration of the acetabular screw through the acetabular cup.2.Superior dislocation of the femoral head with migration of the acetabular cup lateral to the hip.No further evaluation could be performed with the images 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 SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH
• 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: 10114579
• MDR Text Key: 193645267
• Report Number: 0002648920-2020-00284
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024119826
• UDI-Public: 00889024119826
• 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: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• 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: 64574216
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2020
• 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
• Patient Age: 90 YR
• Patient Weight: 84