MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TOTAL HIP BALL 32MM +11; HIP FEMORAL HEAD

Catalog Number	101470000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/24/2017
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
Der states that patient presented with groin pain.Her socket had already been revised once but it was 20 years ago.Parts that were in looked like a depuy hps stem and a duraloc revision shell 62 with a lipped 52 liner.Parts were hard to identify.The stem was still well fixed.Cup, liner, and screws were replaced with multi hole grip, screws, altrx liner, and large taper 36 +11 head.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
No device associated with this report was received for examination.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: TOTAL HIP BALL 32MM +11
• Common Device Name: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6811015
• Report Number: 1818910-2017-23235
• Device Sequence Number: 16660522
• Product Code: JDI
• UDI-Device Identifier: 10603295001270
• UDI-Public: 10603295001270
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K880269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2017

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 Catalogue Number: 101470000
• Device Lot Number: 669450
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 07/24/2017; 09/21/2017
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 08/22/2017; 09/21/2017
• 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: 74 YR
• Patient Weight: 93