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	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	08/16/2010
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 unity record created in order to update legacy complaint# (b)(4): patient was revised to address severe limiting thigh pain.When joint was exposed, severe metallosis was found.Doi: (b)(6) 2008; - dor: (b)(6) 2010; (right hip).Update 1/10/2012 - litigation papers were received.There is no new information that would change the outcome of the investigation.Update 12/31/2012 - pfs and medical record received.The correct doi was provided, (b)(6) 2008.There is no new information that would change the existing mdr decision.Records are available on external hard drive if needed for further review update ad 21 may 2018: (b)(4) has been re-opened under (b)(4) due to receipt of pinnacle ppf and medical records.Ppf has no new allegation that will change the mdr reportability.Corrected doi and implant manufacturing dates.Doi: (b)(6) 2008; dor: (b)(6) 2010; 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 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: 7606515
• Report Number: 1818910-2018-62362
• Device Sequence Number: 16541700
• Product Code: JDI
• UDI-Device Identifier: 10603295033141
• UDI-Public: 10603295033141
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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: 01/04/2011
• Device Catalogue Number: 136516500
• Device Lot Number: 2038879
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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: 45 YR
• Patient Weight: 84