MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,36+8L NK,22X17X165; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number 52-3422

Device Problem Degraded (1153)

Patient Problems Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577)

Event Date 09/13/2021

Event Type  Injury  

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 Description

Clinical notification received for revision of right total hip to address hip dislocation and polyethylene liner wear.Date of implantation: (b)(6) 2002.Date of revision: (b)(6) 2021.(right hip).Treatment: revision of acetabular liner and femoral head.

• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13013862
• MDR Text Key: 282395058
• Report Number: 1818910-2021-25780
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 10603295171058
• UDI-Public: 10603295171058
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/03/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 52-3422
• Device Catalogue Number: 523422
• Device Lot Number: 573034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/1999
• 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: APEX HOLE ELIM POSITIVE STOP; PINN MAR NEUT 28IDX60OD; PINNACLE 100 ACET CUP 60MM; S-ROM*HEAD FEMORAL COCR 28+6; S-ROM*SLEEVE PRX ZTT, 22B-LRG; SROM*STM ST,36+8L NK,22X17X165
• Patient Outcome(s): Required Intervention