MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,30+4L NK,16X11X150; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number 56-3516

Device Problem Migration (4003)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 04/19/2021

Event Type  Injury  

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 Description

It was reported that dr performed the patients initial surgery on (b)(6) 2009.Patient was complaining of some thigh pains.When looking at the x-ray, dr k noticed that stem appeared to have shifted into varus.He decided this could be the cause for her discomfort and felt she would benefit from a removal of the srom stem.The femoral head and stem were removed as well as the acetabular liner.He implanted a competitor stem with their 32mm head.A new liner was implanted for the pinnacle cup and a trial reduction was performed.Hip was found to be stable and the closing process began.Doi: (b)(6) 2009; dor: (b)(6) 2021; right hip.

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 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: a device history record (mre) review, was not possible because the required lot code was not provided.Corrected: g1.

• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11771336
• MDR Text Key: 249001660
• Report Number: 1818910-2021-09502
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 10603295178194
• UDI-Public: 10603295178194
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

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
• Device Operator: Health Professional
• Device Model Number: 56-3516
• Device Catalogue Number: 563516
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/04/2021
• Supplement Dates Manufacturer Received: 05/26/2021
• Supplement Dates FDA Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX +4 10D 32IDX48OD.; DELTA CER HEAD 11/13 32MM +3.; S-ROM*SLEEVE PRX ZTT, 16B-LRG.
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR