MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM M HEAD 36MM +3; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number 1365-32-000

Device Problem Naturally Worn (2988)

Patient Problems Ossification (1428); Hypersensitivity/Allergic reaction (1907); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/30/2012

Event Type  Injury  

Event 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.

Manufacturer Narrative

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

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.

• Brand Name: S-ROM M HEAD 36MM +3
• Type of Device: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13769643
• MDR Text Key: 287187474
• Report Number: 1818910-2022-04680
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033387
• UDI-Public: 10603295033387
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120599
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Model Number: 1365-32-000
• Device Catalogue Number: 136532000
• Device Lot Number: 2587500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 04/07/2022
• Supplement Dates FDA Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2008
• 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: PINN SECTOR W/GRIPTION 50MM; PINNACLE MTL INS NEUT36IDX50OD; S-ROM*SLEEVE PRX ZTT, 14D-SM; S-ROM*STM STD 30 NK 14X8X130
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female