MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX SPA, 16B; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Model Number	53-5362
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The patient was revised to address loosening of the stem at the bone to implant interface.The surgeon performed patient's initial surgery in (b)(6) of 2020.The patient was implanted with a competitor acetabular component and augment, but an srom stem and femoral head.The stem was unfortunately loose and needed to be removed.Dr.Had to perform a femoral shortening in the patient's initial surgery.Unfortunately, the stem did not take to this procedure and appeared to be loose.What remained of the patient's proximal femur was not in the best condition either, so after removing the srom stem and sleeve, dr.Opted to perform a proximal femoral replacement.Doi: (b)(6) 2020; dor: (b)(6) 2021; affected side: right hip.
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 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.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11595405
• Report Number: 1818910-2021-06634
• Device Sequence Number: 3520782
• Product Code: LPH
• UDI-Device Identifier: 10603295172475
• UDI-Public: 10603295172475
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2021

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
• Operator of Device: Health Professional
• Device Model Number: 53-5362
• Device Catalogue Number: 535362
• Device Lot Number: 8313867
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AUGMENT; S-ROM*HEAD FEMORAL COCR 28+0; SROM*STM ST,30+4L NK,16X11X150; STRYKER ACETABULAR COMPONENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR