MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM M HEAD 36MM +3; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number 1365-32-000

Device Problem Off-Label Use (1494)

Patient Problems Osteolysis (2377); Insufficient Information (4580)

Event Date 06/14/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (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

The patient was revised due to osteolysis of a competitor acetabular component.Subsequent head swap of a s-rom femoral component.Doi: unknown - dor: 6 2021 (right hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The reason for revision was to address a competitor manufactured device.Use of this depuy femoral device with competitor manufactured acetabular devices is not recommended and is considered off-label use.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.H10 additional narrative: added: b5 and h6 (investigation conclusions) h6 investigation conclusions: appropriate term/code not available (d17) used to capture cause cannot be traced to device (d10) corrected: h6 (clinical code).

Event Description

Additional information received indicated that surgery time was not extended.No allegation was made against the explanted femoral head.

• Brand Name: S-ROM M HEAD 36MM +3
• Type of Device: 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: 12121076
• MDR Text Key: 260037643
• Report Number: 1818910-2021-14309
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295033387
• UDI-Public: 10603295033387
• Combination Product (y/n): N
• PMA/PMN Number: K120599
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

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: 1365-32-000
• Device Catalogue Number: 136532000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/14/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 07/29/2021
• Supplement Dates FDA Received: 08/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: S-ROM M HEAD 36MM +3; UNKNOWN HIP ACETABULAR CUP (COMPETITOR); UNKNOWN HIP ACETABULAR LINERS (COMPETITOR); S-ROM M HEAD 36MM +3; UNKNOWN HIP ACETABULAR CUP (COMPETITOR); UNKNOWN HIP ACETABULAR LINERS (COMPETITOR)
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR