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

Model Number	1219-32-056
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2021
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
Post tha the patient came back with a dissociated pinnacle poly liner leading to x-ray and will be revised.There was not a depuy head , they have put in a hybrid version with a stem and head from z/b.Due to the metal debris in the joint the or time was longer than expected.Approximately 30-45 minutes to clean out the metal debris from the tissues in the joint.There was a lot of metal debris in the hip joint witch was removed and a new altrx liner was implanted.The pinnacle cup-121731056 lot nr 9660625 was a bit worn on the edge but mostly the debris came from the metal head from z/b that also was exchanged.The head and stem is from z/b.The patient is a male and the affected side is right.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device and provided x-ray image found evidence to support disassociation of the liner from the cup while implanted.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: PINN MAR NEUT 32IDX56OD
• 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: 11590695
• Report Number: 1818910-2021-06493
• Device Sequence Number: 4882024
• Product Code: LPH
• UDI-Device Identifier: 10603295013921
• UDI-Public: 10603295013921
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2021

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: 09/30/2025
• Device Model Number: 1219-32-056
• Device Catalogue Number: 121932056
• Device Lot Number: 9612162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 04/08/2021; 05/12/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 04/15/2021; 05/18/2021
• 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: PINN 100 W/GRIPTION 56MM; PINN MAR NEUT 32IDX56OD; UNKNOWN HIP FEMORAL HEAD; PINN 100 W/GRIPTION 56MM; PINN MAR NEUT 32IDX56OD; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention