MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 14D-SML; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Model Number	55-0503
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Swelling/ Edema (4577)
Date of Event	07/30/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
Mom medical records received.After review of the medical records, the patient was revised to address pseudotumor, elevated metal ions, neurolysis of sciatic nerve, complex wound of hip, heterotopic ossification and capsular redundancy.Operative note reported scars, metallosis, pseudotumor and metallic debris.There was a large amount of fluid present in the hip joint, sciatic nerve was compressed by the pseudotumor.There was also a large amount of capsular debris, pseudotumor and some heterotopic bone.Medical records indicate the cup was loosened and cystic changes were curetted from behind the cup.Doi: (b)(6) 2009; dor: (b)(6) 2012 ; right hip.
Additional 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.
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.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg, ringaskiddy co; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13769631
• Report Number: 1818910-2022-04678
• Device Sequence Number: 19788917
• Product Code: LPH
• UDI-Device Identifier: 10603295175193
• UDI-Public: 10603295175193
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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): 03/15/2022

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: 55-0503
• Device Catalogue Number: 550503
• Device Lot Number: 2516468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PINN SECTOR W/GRIPTION 50MM; PINNACLE MTL INS NEUT36IDX50OD; S-ROM M HEAD 36MM +3; S-ROM*STM STD 30 NK 14X8X130
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female