MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM STM STD 36+12L 13X18; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number 56-3618

Device Problem Fracture (1260)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 07/09/2020

Event Type  malfunction  

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

Clinical adverse event received for implant fracture - s-rom stem.Event is serious and is considered severe.Event is definitely related to device and is definitely not related to procedure.Date of implantation: (b)(6) 2008.Date of event (onset): (b)(6) 2020.(right hip).

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Patient presents with right hip pain.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Examination of provided x-ray images confirms the reported allegations.A fracture of the femoral stem as well as what appears to be a fracture of the sleeve component is identified.Although the allegations of fracture are confirmed it is not possible to conclusively determine the root cause using only x-ray images.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.Corrected: h6 code 3191 (patient) from absence of treatment to device revision or replacement.

• Brand Name: SROM STM STD 36+12L 13X18
• 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: 10307763
• MDR Text Key: 199859956
• Report Number: 1818910-2020-16492
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295178224
• UDI-Public: 10603295178224
• Combination Product (y/n): N
• PMA/PMN Number: P040023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/10/2020

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: 56-3618
• Device Catalogue Number: 563618
• Device Lot Number: 2487868
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 07/22/2020; 08/26/2020
• Supplement Dates FDA Received: 08/06/2020; 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 11/13 S-ROM 40MM M SPEC+3; APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 58MM; PINNACLE MTL INS NEUT40IDX58OD; S-ROM*SLEEVE PRX ZTT, 18D-SML; 11/13 S-ROM 40MM M SPEC+3; APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 58MM; PINNACLE MTL INS NEUT40IDX58OD; S-ROM*SLEEVE PRX ZTT, 18D-SML
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR