MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 36IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-36-056
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	06/07/2020
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
The surgeon was planning on revising a pinnacle liner and head for a patient that underwent a primary daa thr on (b)(6) 2020.The surgeon reported reason for revision was due to the patient dislocating following the primary procedure whilst still an inpatient following the primary procedure.Surgeon advised patient would require a new liner/ liner configuration to improve hip joint stability.Revision surgery completed as planned.No further information available.
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.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.

• Brand Name: PINN MAR NEUT 36IDX56OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10167330
• Report Number: 1818910-2020-14061
• Device Sequence Number: 1800882
• Product Code: LPH
• UDI-Device Identifier: 10603295014461
• UDI-Public: 10603295014461
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: 1219-36-056
• Device Catalogue Number: 121936056
• Device Lot Number: J4706G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2020
• Supplement Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORAIL AMT SZ18 135 HIGH COL; DELTA CER HEAD 12/14 36MM +12; PINN CAN BONE SCREW 6.5MMX30MM; PINN SECTOR HA ACET CUP 56MM; CORAIL AMT SZ18 135 HIGH COL; DELTA CER HEAD 12/14 36MM +12; PINN CAN BONE SCREW 6.5MMX30MM; PINN SECTOR HA ACET CUP 56MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR