MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH; PROSTHETIC, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Material Deformation (2976)

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

Event Date 05/24/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical product: 110010242 g7 osseoti 3 hole shell 48mm c lot number 65671784.Foreign: japan.The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Device remains implanted.

Event Description

It was reported that the screw went through the screw hole of the g7 cup.The surgeon confirmed via x-ray that the screw head appeared to have been damaged.It appears that the head of the screw was stripped/deformed during insertion.The patient is currently under observation.There is no additional information at the time of this report.

Manufacturer Narrative

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 0001822565 - 2023 - 02709.Sections updated: b4.B5.G3.G6.H2.H10.

Event Description

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 0001822565 - 2023 - 02709.

• Brand Name: BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH
• Type of Device: PROSTHETIC, 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: 17266600
• MDR Text Key: 318512253
• Report Number: 0002648920-2023-00140
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/03/2023

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 Model Number: N/A
• Device Catalogue Number: 00625006520
• Device Lot Number: J7454436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 10/02/2023
• Supplement Dates FDA Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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