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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Physical Asymmetry (4573)
Date of Event	08/12/2010
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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.

• Common Device Name: 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
• Report Number: 1818910-2021-00311
• Device Sequence Number: 14463645
• Product Code: LWH
• UDI-Device Identifier: 10603295171041
• UDI-Public: 10603295171041
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2020

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?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR