MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*HEAD FEMORAL COCR 22+0; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number	52-2022
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/08/2021
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
Dr has unfortunately had to perform several revisions with this patient.The only one i was able to pull up records for was the most previous revision done in (b)(6) 2020.This patient suffers from ehlers danlos syndrome.Dr had an srom stem and 22mm head in, with a competitor acetabular component.The patient was feeling some impinging of their hip, so dr (b)(6) opted to change out the competitor liner, as well as the srom stem and head.A 16 x 11 x 150 30+4 stem was removed and a 16 x 11 x 150 36 +6 was implanted.The srom sleeve was left alone.A trial reduction was performed with a 36mm +0 head and found to be stable.Dr believed the additional offset helped with the patients impinging on their acetabular component.The real 36mm +0 ceramic head was opened and implanted.The closing process began.Doi: (b)(6) 2020.Dor: (b)(6) 2021; left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.It has been reported the depuy femoral head was used in conjunction with competitor manufactured acetabular products.This is not recommended and is considered off label use.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.

• Common Device Name: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11201647
• Report Number: 1818910-2021-01522
• Device Sequence Number: 2947204
• Product Code: JDI
• UDI-Device Identifier: 10603295170778
• UDI-Public: 10603295170778
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• 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): 01/08/2021

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: 52-2022
• Device Catalogue Number: 522022
• Device Lot Number: 8374695
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 02/23/2021
• 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: S-ROM*HEAD FEMORAL COCR 22+0; SROM*STM ST,30+4L NK,16X11X150; STRYKER; STRYKER; UNK HIP FEMORAL SLEEVE SROM; S-ROM*HEAD FEMORAL COCR 22+0; SROM*STM ST,30+4L NK,16X11X150; STRYKER; STRYKER; UNK HIP FEMORAL SLEEVE SROM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR