MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SCREW,6.5MM DIA,35MM LG; BONE SCREWS AND PINS : SCREWS

Model Number 55-6074

Device Problems Fracture (1260); Off-Label Use (1494); Osseointegration Problem (3003)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Inadequate Osseointegration (2646)

Event Date 05/23/2022

Event Type  Injury  

Event Description

It was reported that on april 9, 2007, the patient underwent a tha surgery for oa of hip.After surgery, the screws broke due to loosening of a cup, and the patient had pain.On (b)(6) 2022, a revision surgery was performed with no surgical delay.In the revision surgery, the stem was kept using as it was, and the cup was replaced.The loosened cup is a competitor¿s product.The surgeon commented that the cause of loosening of the cup might have been due to alval (aseptic lymphocytic vasculitis-related lesion) since the implants implanted in a state of mom.No further information is available.

Manufacturer Narrative

Product complaint # pc-(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information, which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained, that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # : (b)(4) investigation summary : device associated with this report was not received for examination.All available x-rays and photographs were reviewed.The screw has fractured at the threaded portion.The screw was used off label use with a competitor cup.Implant loosening cannot be confirmed without a series of x-rays images.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14633732
• MDR Text Key: 293564905
• Report Number: 1818910-2022-10416
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295175940
• UDI-Public: 10603295175940
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K951000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2022

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: Health Professional
• Device Model Number: 55-6074
• Device Catalogue Number: 556074
• Device Lot Number: 313261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 06/08/2022
• Supplement Dates Manufacturer Received: 06/13/2022; 08/18/2022
• Supplement Dates FDA Received: 06/16/2022; 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2002
• 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: ARTICULEZE M HEAD 36MM +8.5; COMPETITOR CUP; G2 PRESS FIT STEM SZ7L; PINNACLE MTL INS NEUT36IDX56OD; S-ROM*SCREW,6.5MM DIA,30MM LG; S-ROM*SCREW,6.5MM DIA,35MM LG
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR
• Patient Sex: Male