MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PRODIGY SM STAT LNG RT 13.5MM; HIP FEMORAL STEM/SLEEVE

Catalog Number	152021050
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671)
Date of Event	04/18/2017
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
New etq created in order to update etq (legacy system) (b)(4).Reason for original complaint- litigation alleges that after the surgical implantation of the asr hip implant device, patient suffered symptoms and damage to her body including but not limited to pain and discomfort; the formation of metallosis and pseudotumors which have damaged bone and tissue surrounding the implant; stiffness; inflammation; chromium and cobalt metal toxicity; lack of mobility; and other complications.**update** 10/03/2013- plaintiff¿s preliminary disclosure form was received, which identified side, dob, and part/lot information.The complaint and associated mdrs were updated.There was no new information that would change the outcome of the investigation.Update jul 18, 2017: medical records received.After review of the medical records for mdr reportability, in addition to what was previously alleged, revision notes reported fluid in the hip joint and metal wear debris on the trunnion.There was no mention of metallosis or pseudotumors.No laboratory values provided for the alleged chromium-cobalt toxicity.Stem and sleeve were added due to the reported metal wear and chromium-cobalt toxicity.Product information was updated.This complaint was updated on: aug 7, 2017.
Additional Manufacturer Narrative
No device associated with this report was received for examination.Depuy considers the investigation closed at this time.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.

• Brand Name: PRODIGY SM STAT LNG RT 13.5MM
• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6800160
• Report Number: 1818910-2017-22912
• Device Sequence Number: 531681
• Product Code: LPH
• UDI-Device Identifier: 10603295056874
• UDI-Public: 10603295056874
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K000207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2017

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: 152021050
• Device Lot Number: B5KCE1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 01/11/2018
• 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: 71 YR