MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 S-ROM*HEAD FEMRL ALUMINA 32+0; S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS

Catalog Number	528323
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2018
Type of Reportable Event	Malfunction
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
Der states that the new srom alumina/ titanium 11/13 taper 32 mm heads have grossly inadequate labeling.It was also reported that it is not labeled titanium sleeve or anything indicating a sleeve.The only indication is on the underside which next to metal has a ''ti'' next to it.Doe: (b)(6) 2018, right hip.
Additional Manufacturer Narrative
Product complaint # : (b)(4).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 CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7536911
• Report Number: 1818910-2018-60323
• Device Sequence Number: 11237370
• Product Code: JDI
• UDI-Device Identifier: 10603295171478
• UDI-Public: 10603295171478
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K913231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 528323
• Device Lot Number: 8339429
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 116