MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 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 01/10/2024

Event Type  malfunction  

Event Description

It was reported that during a total hip procedure, the screws used to attach the cup did not seat and drilled completely through.There was a surgical delay of two (2) hours while the screws and shell were removed and replaced with a second set of implants.No patient impact has been reported as a result of the malfunction.Due diligence is in progress for this event; to date no further information has been reported.

Manufacturer Narrative

(b)(4).D10: medical product: 60mm cup size revision shell: catalog#00700006020, lot#65641020; bone screw self-tapping 6.5 mm dia.30 mm length: catalog#00625006530, lot#j6858515; bone screw self-tapping 6.5 mm dia.30 mm length: catalog#00625006530, lot#j7394928; 0 degree face angle 36mm i.D.Cemented revision shell liner use with 60mm o.D.Shell: catalog#00710506036, lot#64955355.G2: foreign: germany.Multiple mdr reports have been filed for this event.Please see associated reports: 0001822565-2024-00218; 0001822565-2024-00220; 0001822565-2024-00221.Diligence is in process to determine whether the product is available for evaluation.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.H3 other text : see h10 narrative.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h6.Visual examination of the returned devices identified three of seven screw holes of the shell are damaged.All three bone screws show surface damage / witness marks on the shanks near the head.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial tha was performed on an unknown date with unknown product.The patient was revised due to cup loosening with acetabular bone defects and cysts.When trying to place the tm shell, the screw went through the shell.A different shell was used to complete the procedure.The root cause of the reported issue is attributed to user error, as the surgeon used incompatible screws with the tmars shell, causing them to pull through and damage the shell.Per the ifu, it states not to use this product for other than labeled indications (off label use).A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.If any further information is found which would change or alter any conclusions or information, a supplemental report 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.

• Brand Name: BONE SCREW SELF-TAPPING 6.5 MM DIA. 35 MM LENGTH
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18554704
• MDR Text Key: 333441071
• Report Number: 0001822565-2024-00222
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024119833
• UDI-Public: (01)00889024119833(17)310710(10)J7061001
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• 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: J7061001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Sex: Prefer Not To Disclose