MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SROM 28MM +0 M HEAD; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Catalog Number	136516500
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Discomfort (2330); Test Result (2695)
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.Concomitant med products: srom 28mm +0 m head hip femoral head; pinnacle mtl ins neut28idx48od hip acetabular liner; unknown hip acetabular cup; srom*stm st,36+8l nk,20x15x165 hip femoral stem; unknown hip proximal femoral sleeve.Initial reporter occupation: non-healthcare professional ¿ attorney.
Event or Problem Description
Litigation papers allege: on or about (b)(6) 2004, patient was implanted with a depuy pinnacle hip on her right side.Patient has large amounts of cobalt chromium metal ions and particles in her blood, tissue, and bone surrounding the implant.Patient has been experiencing severe pain and discomfort and inflammation in her right thigh and groin.She also experiences a popping and snapping sensation in her hip-joint when walking or moving to and from a sitting position.Patient will likely need to undergo revision surgery to replace the implant.Doi: (b)(6) 2004 ; dor: none reported (right 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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SROM 28MM +0 M HEAD
• Common Device Name: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8055836
• Report Number: 1818910-2018-75147
• Device Sequence Number: 1484845
• Product Code: JDI
• UDI-Device Identifier: 10603295033141
• UDI-Public: 10603295033141
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2018

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 Expiration Date: 02/28/2009
• Device Catalogue Number: 136516500
• Device Lot Number: 1169982
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 01/16/2019
• 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