MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 G2 PRESS FIT STEM SZ6L G2 CEMENTED AND CEMENTLESS STEMS : HIP FEMORAL STEM

Catalog Number 900000126

Device Problem Loss of Osseointegration (2408)

Patient Problems Bone Fracture(s) (1870); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that patient fractured left femur. Surgeon removed g2 femoral stem pinnacle liner and femoral head. Surgeon used a long stem to revise. Cup remained implanted. It was also indicated that there was a loosening of the stem at bone to implant interface. Doi: (b)(6) 2003, dor: (b)(6) 2020, affected side: left hip.

• Brand Name: G2 PRESS FIT STEM SZ6L
• Type of Device: G2 CEMENTED AND CEMENTLESS STEMS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10160930
• MDR Text Key: 195387790
• Report Number: 1818910-2020-13933
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 900000126
• Device Lot Number: 1058206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2002
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/17/2020 Patient Sequence Number: 1

Treatment

ARTICUL/EZE BALL 32 +5 BR; G2 PRESS FIT STEM SZ6L; PINN MAR +4 NEUT 32IDX54OD; PINNACLE SECTOR II CUP 54MM