MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 28IDX44OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-28-044
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104); Discomfort (2330); No Code Available (3191)
Date of Event	02/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).(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
Reason for revision; pain and discomfort, diagnosed as a femoral nerve palsy.Patient complaining of pain and discomfort.Symptoms consistent with femoral nerve palsy.Investigations (mri) and second opinion consulted.Radiologist opinion and various orthopaedic opinion suggest an acetabular cancellous bone screw despite being only 25mm long may have perforated the boney pelvic wall and caused irritation of the femoral nerve.This was purely a suspicion based on collective opinion as a potential possible cause.The patient is very small in stature and has dysplasia of the hip.(acetabular component only 44mm).The patient's hip when reduced resulted in a leg lengthening of over one cm to correct the shortening of the affected leg associated with the dysplasia of the hip.The polyethylene liner was removed and the screw removed without incident.The liner was then replaced with an identical new 28mm neutral 44mm polyethylene pinnacle acetabular liner.The ceramic femoral head remained insitu on the corail femoral stem during the liner removal, screw removal, and liner replacement.The hip was then reduced and clinical stability was achieved with a range of motion prior to wound and soft tissue closure.Relevant patient pre-existing conditions/ comorbidities; developmental dysplastic hip.Information regarding the suspected femoral palsy and the post operative result regarding pain etc is not available at this time.A depuy synthes representative was not present during the revision surgery however was spoken to over the phone prior to and after the completion of the revision surgery.No further information available.Patient dob unavailable.Both the patient and surgeon have not consented to any information being shared regarding the primary and revision procedures including the information contained in this document.A copy of the original primary prosthesis are attached to this email.Please note only one 25mm cancellous acetabular bone screw was removed.The second screw remains insitu.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot null device history batch null device history review null 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 NEUT 28IDX44OD
• 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: 9813871
• Report Number: 1818910-2020-07402
• Device Sequence Number: 16836649
• Product Code: LPH
• UDI-Device Identifier: 10603295013266
• UDI-Public: 10603295013266
• 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): 02/19/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: 1219-28-044
• Device Catalogue Number: 121928044
• Device Lot Number: J4654C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 04/01/2020
• 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: APEX HOLE ELIM POSITIVE STOP; CORAIL2 LAT COXA VARA SIZE 10; DELTA CER HEAD 12/14 28MM +1.5; PINN BANTAM W/GRIPTION 44MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN MAR NEUT 28IDX44OD
• Outcome Attributed to Adverse Event: Required Intervention