MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCR 6.5X30 SELF-TAP; PROTHESIS, HIPS

Model Number N/A

Device Problems Fracture (1260); Migration (4003)

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

Event Date 12/01/2023

Event Type  Injury  

Event Description

It was reported the screw penetrated the cup postoperatively.A revision surgery was performed to remove it immediately.The screw was successfully removed, the cup was reinserted, and the procedure was completed.

Manufacturer Narrative

(b)(4).G2: foreign: japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.D10: 110010243 g7 osseoti 3 hole shell 50mm d 65616772.30103204 32mm i.D.Size d neutral liner 65698563.

Event Description

No additional event information to report at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

Visual examination of the returned product identified screw is deformed and damaged around the head circumference with a fractured fragment on the head of the screw.Damage on the head shows burrs.Hex shows nicks and gouges from use.Distal threads and taper below head show deformation and witness marks from insertion.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: recent right total hip arthroplasty with one of two screws which have penetrated the acetabular cup and is seated completely within the bone.A definitive root cause cannot be determined.This complaint was confirmed based on the provided x-rays confirming the reported event.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.

• Brand Name: BONE SCR 6.5X30 SELF-TAP
• Type of Device: PROTHESIS, HIPS
• 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: 18598850
• MDR Text Key: 334028748
• Report Number: 0001822565-2024-00299
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024119826
• UDI-Public: (01)00889024119826(17)330130(10)J7439028
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00625006530
• Device Lot Number: J7439028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 02/01/2024; 04/30/2024
• Supplement Dates FDA Received: 02/02/2024; 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2023
• 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
• Patient Outcome(s): Hospitalization; Required Intervention