MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,36+8L NK,20X15X165; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number 52-3420

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Physical Asymmetry (4573)

Event Date 08/12/2010

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.Follow up is being conducted to determine the legal contact information.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Asr supplemental info and medical records were received.After a review of the medical record, the patient was revised to address right total hip arthroplasty failure secondary to leg-lengthening excessively and calcar fracture.Operative note reported that the femoral neck was noted to have cracked during the insertion of the new stem.Doi: (b)(6) 2009.Dor: (b)(6) 2010.Right 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.Corrected: e1 (reporter's name) and removed facility name since the complaint is legal.

• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11118834
• MDR Text Key: 226632908
• Report Number: 1818910-2021-00311
• Device Sequence Number: 1
• Product Code: LWH
• UDI-Device Identifier: 10603295171041
• UDI-Public: 10603295171041
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2014
• Device Model Number: 52-3420
• Device Catalogue Number: 523420
• Device Lot Number: 2877611
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVE 11/13 +0; ASR 300 SPIKED CUP SIZE 58; ASR UNI FEMORAL IMPL SIZE 51; S-ROM*SLEEVE PRX ZTT, 20F-XXL; SROM*STM ST,36+8L NK,20X15X165
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR