MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DEPUY CMW 3 40G; BONE CEMENT : BONE CEMENT

Model Number 3332-040

Device Problems Off-Label Use (1494); Migration (4003)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/15/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Asr litigation records received alleging injury, economic loss, pain, impairment in the plaintiff's ability to perform normal daily activities including walking and sleeping, increased blood metal ion levels and suffering.The stem was grossly loose and revised.The outer shell bone interface had some movement and was revised with minimal bone loss.Doi: (b)(6) 2006 (cup, head, sleeve, cement), doi: (b)(6) 2002 (stem), dor: (b)(6) 2017 left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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.

• Brand Name: DEPUY CMW 3 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11966769
• MDR Text Key: 255133017
• Report Number: 1818910-2021-12205
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 10603295168638
• UDI-Public: 10603295168638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2009
• Device Model Number: 3332-040
• Device Catalogue Number: 3332040
• Device Lot Number: 2171294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2006
• 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: ADAPTER SLEEVES 12/14 +8; ASR ACETABULAR CUPS 46; ASR UNI FEMORAL IMPL SIZE 41; DEPUY CMW 3 40G; DEPUY CMW 3 40G; ZIMMER VERSYS CEMENTED STEM(COMPETITOR); ADAPTER SLEEVES 12/14 +8; ASR ACETABULAR CUPS 46; ASR UNI FEMORAL IMPL SIZE 41; DEPUY CMW 3 40G; DEPUY CMW 3 40G; ZIMMER VERSYS CEMENTED STEM(COMPETITOR)
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male