MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM STM STD 36+12L 17X22; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number	56-3622
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/23/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).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
Clinical adverse event received for intraoperative bone fracture.Event is serious.Event is possibly related to device and is probably related to procedure.On (b)(6) 2010, the patient underwent a primary right hip arthroplasty due to avascular necrosis.During impaction of the acetabular cup, a small fracture was noticed in the posterior wall.The acetabular fracture was corrected intra-operatively with a 5-hole small fragment pelvic reconstruction plate along with four screws.Date of implantation: (b)(6) 2010, date of event (onset): (b)(6) 2010, (right hip).

• Brand Name: SROM STM STD 36+12L 17X22
• 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: 11342758
• Report Number: 1818910-2021-03238
• Device Sequence Number: 3347369
• Product Code: JDI
• UDI-Device Identifier: 10603295178248
• UDI-Public: 10603295178248
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

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 Model Number: 56-3622
• Device Catalogue Number: 563622
• Device Lot Number: 2844684
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 162