MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 11/13 28MM +0; S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS

Catalog Number	136528210
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Limited Mobility Of The Implanted Joint (2671)
Date of Event	10/10/2011
Type of Reportable Event	Serious Injury
Additional 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.Device was used for treatment, not diagnosis.Initial reporter occupation: non-healthcare professional: "attorney".
Event or Problem Description
Litigation papers allege: corrosion and friction wear caused large amounts of toxic cobalt-chromium metal ions and particles to be released into patient's blood and tissue and bone surrounding the implant; since surgery, patient has suffered symptoms including, but not limited to pain, swelling, soreness, difficulty walking, decreased mobility and/or the need for revision surgery.Update: although litigation reported this as metal on metal, product information indicates the patient had poly on metal.Doi: (b)(6) 2008; dor: not reported; (left hip).
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.Information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DELTA CER HEAD 11/13 28MM +0
• Common Device Name: S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8340390
• Report Number: 1818910-2019-84615
• Device Sequence Number: 16573454
• Product Code: LPH
• UDI-Device Identifier: 10603295033240
• UDI-Public: 10603295033240
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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 Expiration Date: 02/28/2012
• Device Catalogue Number: 136528210
• Device Lot Number: 2343178
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 12/10/2019
• 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: Other
• Patient Age: 85 YR
• Patient Weight: 100