MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM*HEAD FEMORAL COCR 32+6; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Catalog Number	522033
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	04/12/2011
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 papers allege since surgical implantation, patient has suffered symptoms including, but not limited to pain, soreness and difficulty walking.Doi: (b)(6) 2009 - dor: no revision reported at this time.(right side) pfs was received from legal, medical records were received from legal, and part/lot information was identified.Although litigation reported this as metal on metal, product information indicates the patient had poly on metal.As the litigation has already been reported, and there is no reported serious injury or malfunction (patient has not been revised), the reporting requirements have been met.Even though part/lot information was provided it is unclear what products are at issue as the patient has not been revised therefore the product page will be left as unknown until further information is received.Records are available for further review.Ppf and implant sticker sheet received.There is no new allegation to be reported.Doi: (b)(6) 2009 ; dor: not reported; right hip; pinnacle.
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.

• 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: 7498257
• Report Number: 1818910-2018-59179
• Device Sequence Number: 19274728
• Product Code: JDI
• UDI-Device Identifier: 10603295170839
• UDI-Public: 10603295170839
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2018

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: 03/21/2013
• Device Catalogue Number: 522033
• Device Lot Number: 2586689
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 09/19/2018
• 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: 42 YR
• Patient Weight: 98