MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 32IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	122132056
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
It was reported that the poly liner became dislodged from cup.Patient stated that he was dancing and felt a ¿pop¿ in his hip and knew something was not right.Patient went to the emergency room, after x-rays and ct scan it was verified that the liner had dislodged from the cup.The surgeon did not know if the liner was defective or if there was impingement that could have caused the separation of the liner.Surgeon revised the acetabular cup because he felt the position of the cup was not optimal.Doi: (b)(6) 2017; dor: (b)(6) 2018; right hip.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ALTRX NEUT 32IDX56OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7800647
• Report Number: 1818910-2018-67202
• Device Sequence Number: 14044674
• Product Code: LPH
• UDI-Device Identifier: 10603295016137
• UDI-Public: 10603295016137
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2018

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: 122132056
• Device Lot Number: H09202
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 09/24/2018
• 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: 59 YR