MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCR 6.5X35 SELF TAP; PROSTHETIC, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

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

Event Date 08/02/2023

Event Type  malfunction  

Event Description

It was reported that when the cup was implanted, the surgeon needed a screw for better fixation.While tightening the screw, it was over tightened resulting in the screw going through the cup.The cup, screw, and liner were all removed and replaced with identical implants.There is no additional information available at the time of this report.

Manufacturer Narrative

(b)(4).D10: 010000661, item name: g7 pps ltd acet shell 48c, lot #: 7151430; 20123203, item name: g7 longevity high wall 32mm c, lot #: 65569297.G2: foreign: canada.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: limited evaluation of a right total hip arthroplasty with single screw which has penetrated through the implant and implanted fully into bone.It was stated the surgeon thinks he may have over tightened the screw but a definitive root cause cannot be determined.This complaint was confirmed based on the provided x-rays.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.H3 other text : device location is unknown.

Event Description

It was reported that when the cup was implanted, the surgeon needed a screw for better fixation.While tightening the screw, the surgeon believes it was over tightened resulting in the screw going through the cup.The cup, screw, and liner were all removed and replaced with identical implants.There is no additional information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4 g3 g6 h2 h10 corrected: b5.

• Brand Name: BONE SCR 6.5X35 SELF TAP
• Type of Device: PROSTHETIC, 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: 18371457
• MDR Text Key: 331313075
• Report Number: 0001822565-2023-03714
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024119833
• UDI-Public: (01)00889024119833(17)321208(10)J7410192
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00625006535
• Device Lot Number: J7410192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PLEASE SEE H10.
• Patient Sex: Prefer Not To Disclose