MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 PINN MAR +4 10D 36IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121936156
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/13/2018
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) 2018 - primary implant date: (b)(6) 2012.Revision: possible stem loosening and possible cause of patient's report of pain.Lucent line on x-ray imaging along the proximal end of stem.Good bone growth evident in distal two thirds of femoral stem.Nil signs of infection.Male patient id: (b)(6) years; dob: (b)(6).
Additional Manufacturer Narrative
Pc-(b)(4).No device associated with this report was received for examination.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: PINN MAR +4 10D 36IDX56OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7669635
• Report Number: 1818910-2018-63918
• Device Sequence Number: 920345
• Product Code: LPH
• UDI-Device Identifier: 10603295014591
• UDI-Public: 10603295014591
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2018

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 Catalogue Number: 121936156
• Device Lot Number: 193336
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 08/31/2018
• 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: 56 YR