MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING 6.5 MM DIA. 35 MM LENGTH; PROSTHESIS, HIP

Catalog Number 00625006535

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2022

Event Type  malfunction  

Event Description

It was reported that during the revision procedure, the screws fell through the cup.There were no health consequences or impact to the patient.Attempts have been made and no further information is available.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00513, 0001822565-2023-00514, 0001822565-2023-00516 and shell: 0001822565-2023-00518.Bone screw self-tapping 6.5 mm dia.40 mm length/00625006540/j6833188.Bone screw self-tapping 6.5 mm dia.25 mm length/00625006525/j7051454.Bone screw self-tapping 6.5 mm dia.30 mm length/00625006530/j7144345.G7 osseoti multihole 70mm i/110010273/6416662.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

Upon receiving additional information of the reported event, it was determined to be not reportable as this product was not involved in the event.The initial report should be voided.

Manufacturer Narrative

Upon receiving additional information of the reported event, it was determined to be not reportable as this product was not involved in the event.The initial report should be voided.

• Brand Name: BONE SCREW SELF-TAPPING 6.5 MM DIA. 35 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
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16461845
• MDR Text Key: 310456062
• Report Number: 0002648920-2023-00029
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024119833
• UDI-Public: (01)00889024119833(17)280831(10)64129635
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

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 Catalogue Number: 00625006535
• Device Lot Number: 64129635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 127 KG