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

Model Number 52-1483

Device Problems Fracture (1260); Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Bone Fracture(s) (1870); Joint Disorder (2373); No Code Available (3191)

Event Date 07/26/2016

Event Type  Injury  

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.

Event Description

Pfs and medical records received.After review of the medical records the patient was revised on (b)(6) 2016.The pfs indicated the patient was revised for dislocation and a fractured stem.The stem has already been reported on (b)(4).Part/ lot hasn't been provided at this time.Ppf has no new allegations reported.After review of medical records, the patient was revised to perform an excisional irrigation and debridement as well as an extended trochanteric osteotomy of the hip to address dislocation, extensive metallosis and damaged trunnion of the femoral component.Updated the implant date of the head and the details of the impacted products.Doi: (b)(6) 2015 (head), doi: (b)(6) 2016 (liner), dor: (b)(6) 2016 (left hip).

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: investigative update: 29 / oct / 2021.X-ray images have been provided for review.No device associated with this report was received for examination.X-ray images have been provided for review.None of the allegations reported regarding the femoral sleeve component can be verified.Nothing indicative of a product problem is identified.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 material, manufacturing, inspection or sterile processing 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 IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9409781
• MDR Text Key: 184815866
• Report Number: 1818910-2019-120095
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295170631
• UDI-Public: 10603295170631
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934412
• 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: 10/14/2016

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: 52-1483
• Device Catalogue Number: 521483
• Device Lot Number: 2931505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: 12/06/2021
• Supplement Dates FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2009
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Sex: Female
• Patient Weight: 70 KG