MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 18F-SML; HIP FEMORAL STEM/SLEEVE

Catalog Number	550525
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Bone Fracture(s) (1870); Hematoma (1884); Pain (1994); Scarring (2061); Swelling (2091); Tissue Damage (2104); Discomfort (2330); Osteolysis (2377); Claudication (2550); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	06/13/2017
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.
Event or Problem Description
Litigation record received.Litigation alleges friction and wear causing toxic metal ions and particles, pain, popping sensation, metallosis, and trochanteric osteolysis.There are no medical records provided.Pfs and medical records received.In addition to what previously alleged, pfs also alleges discomfort, limited mobility, limping, and inability to effectively perform activities of daily living.After review of medical records for mdr reportability, it was stated that the patient was revised to address metallosis, pain, trochancentric osteolysis, and pathologic fracture of the greater trochanter.Revision notes reported darkened bursa and scarring.Mri report suggests soft tissue swelling, small hematoma, and fatty atrophy.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary: no device associated with this report was received for examination.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.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
Complaint description: sep 21, 2017: litigation record received.Litigation alleges friction and wear causing toxic metal ions and particles, pain, popping sensation, metallosis, and trochanteric osteolysis.There are no medical records provided.Update oct 06, 2017: pfs and medical records received.In addition to what previously alleged, pfs also alleges discomfort, limited mobility, limping, and inability to effectively perform activites of daily living.After review of medical records for mdr reportability, it was stated that the patient was revised to address metalosis, pain, trochancentric osteolysis, and pathologic fracture of the greater trochanter.Revision notes reported darkened bursa and scarring.Mri report suggests soft tissue swelling, small hematoma, and fatty atrophy.Updated product information.This complaint was updated on: oct 24, 2017.

• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7002164
• Report Number: 1818910-2017-28153
• Device Sequence Number: 1184734
• Product Code: LPH
• UDI-Device Identifier: 10603295175308
• UDI-Public: 10603295175308
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2017

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: 550525
• Device Lot Number: 614200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 11/04/2017
• Supplement Report FDA Received Date: 06/28/2018
• 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: 65 YR
• Patient Weight: 88