MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 12/14 ARTICUL 44MM M SPEC+1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number	136561000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
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
Complaint description: new etq created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint- litigation papers allege the patient may have to undergo painful and risky revision surgery due to the hip implant not functioning as intended.Update ad 04 may 2018: (b)(4) has been re-opened under (b)(4) due to receipt of pinnacle ppf record.There was no new allegation(s) reported.Implant sticker was also received, which part and lot identified.Added products from sticker sheet since there has been no revision and it is a known poly liner with pain was alleged previously and no allegations of metal on metal issues-we can't really exclude any of the products as the cause of the pain.Lawyer firm, manufacturing dates, expiration date, dob were updated as well.Doi: (b)(6) 2009; dor: not reported; left hip.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
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: 12/14 ARTICUL 44MM M SPEC+1.5
• Common Device Name: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7562143
• Report Number: 1818910-2018-61162
• Device Sequence Number: 19381711
• Product Code: JDI
• UDI-Device Identifier: 10603295034032
• UDI-Public: 10603295034032
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: 136561000
• Device Lot Number: 2581818
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2018
• Supplement Date Received by Manufacturer: 08/14/2018; 10/16/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 08/14/2018; 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1