MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 18D-SML; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Model Number 55-0523

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Foreign Body Reaction (1868); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Osteolysis (2377); Impaired Healing (2378); Unspecified Tissue Injury (4559)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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.

Event Description

Litigation record received.Litigation alleges that the patient was diagnosed with dense fibrous tissue and focal synovium with foci of degeneration, hemorrhage, mild chronic lymphohistiocytic inflammation, hemosiderosis, metallosis, rare foreign body giant cells, and abundant fibrin of the right hip bone and tissue.Doi: (b)(6) 2018, dor: not reported, right hip.(b)(4) first revision.(b)(4) second revision.(b)(4) third revision.

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.

• Type of Device: 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 ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14336241
• MDR Text Key: 291201944
• Report Number: 1818910-2022-08431
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295175285
• UDI-Public: 10603295175285
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

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
• Device Operator: Health Professional
• Device Model Number: 55-0523
• Device Catalogue Number: 550523
• Device Lot Number: 1083632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 05/09/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2003
• 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: (8) ZIMMER BONE SCREWS; S-ROM HEAD FEMORAL COCR 32+3; S-ROM*SLEEVE PRX ZTT, 18D-SML; SROM*STM ST,36+8L NK,18X13X160; STRYKER BONE CEMENT; ZIMMER CONSTRAINED LINER; ZIMMER CUP
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female