MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZT HA 18D-LRG; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number 550149

Device Problems Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 06/02/2020

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

The patient was in pain and had developed a limp.Primary implant date: (b)(6) 2005.Revising a pinnacle asr/srom the surgeon discovered the neck (36 + 12mm) had bent and disconnected from the stem.The original plan was to replace the liner and head from metal on metal articulation to a poly/ceramic or ceramic/ceramic.After opening the surgeon noted that the stem was loose.The neck of the srom stem was disconnected from the stem and sleeve.They replaced the stem with a sized 11 corail kho.The surgeon was able to pull it out with his hand.Rep present.Male patient, id: (b)(6), dob: (b)(6).No delay in the surgery.

Event Description

A review of the provided photo confirms a fracture of the femoral stem having occurred just below the proximal edge of the sleeve.This would be the reason the stem appeared "bent" in the provided x-ray image.There was no disassociation of the stem/sleeve construct.Based on the information now available it would be most appropriate to code the stem and sleeve for loosening and the stem for material fracture metal.

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.¿.

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.¿ no code available is used to capture walking difficulty and device revision or replacement.

Manufacturer Narrative

Product complaint #(b)(4).Investigation summary: no device associated with this report was received for examination.However a photograph was provided which confirms a fracture of the femoral stem having occurred just below the proximal edge of the sleeve.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.

• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10155105
• MDR Text Key: 195168672
• Report Number: 1818910-2020-13803
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K912713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 550149
• Device Lot Number: 1209752
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX35MM; PINN SECTOR HA ACET CUP 54MM; PINNACLE MTL INS NEUT36IDX54OD; S-ROM M HEAD 36MM +9; S-ROM*STM STD,30 NK,18X13X160; SROM STM STD 36+12L 13X18; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL AUGMENT; UNKNOWN HIP FEMORAL HEAD; S-ROM*STM STD,30 NK,18X13X160; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL AUGMENT; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR