MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.1818910 PINNACLE 100 HA ACET CUP 52MM; HIP ACETABULAR CUP

Catalog Number	121711052
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Pain (1994)
Date of Event	03/19/2016
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
On (b)(6) 2017: email notification received.There is no report of adverse event at this time.Update oct 9, 2017: additional information received.Patient was revised to address achey, fluid collection in hip, high metal ions and valgus alignment.Product codes and lot numbers updated.
Additional Manufacturer Narrative
Aug 15, 2017: email notification received.There is no report of adverse event at this time.The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.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: PINNACLE 100 HA ACET CUP 52MM
• Common Device Name: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7005531
• Report Number: 1818910-2017-28210
• Device Sequence Number: 13735701
• Product Code: LPH
• UDI-Device Identifier: 10603295009061
• UDI-Public: 10603295009061
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K031495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2017

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 Expiration Date: 07/09/2018
• Device Catalogue Number: 121711052
• Device Lot Number: C1PF91000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR