MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SROM*STM ST,30+4L NK,14X09X130; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number	563514
Medical Device Problem Codes	Fracture (1260); Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Inadequate Osseointegration (2646); Not Applicable (3189)
Date of Event	04/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.No 510(k) number provided because this implant product code is sold internationally.It is sold in the us under a different product code.
Event or Problem Description
Customer reported to bfarm: hip-tep right side on (b)(6) 1999.Osteolysis and pe wear.Revision of head and inlay in 2013.Now since months pain in the right hip.X-ray showed fractured stem.Punction of right hip: sterile: change of stem right hip on (b)(6) 2018.
Additional Manufacturer Narrative
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
After review of the medical records on 3 jul 2018, it was discovered the patient underwent a revision surgery on (b)(6) 2013 due to loosening of the stem and sleeve as well as a greater trochanter fracture.A lesser trochanter fracture was discovered during the second revision on (b)(6) 2018.There is no evidence the stem and sleeve were removed during the first revision surgery on (b)(6) 2018.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: following inspection of the returned products and review of the information received, it was concluded that it was unlikely that a manufacturing defect was present.The complaint shall be closed with an undetermined conclusion, it shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.Device history lot = > null device history batch = > null device history review = > null if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582 0988
• MDR Report Key: 7521653
• Report Number: 1818910-2018-59823
• Device Sequence Number: 1626676
• Product Code: JDI
• UDI-Device Identifier: 10603295178187
• UDI-Public: 10603295178187
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 563514
• Device Lot Number: 588466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 06/04/2018; 07/23/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 07/03/2018; 08/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR