MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 NEUT 36IDX54OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-36-454
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
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 patient was diagnosed with osteoarthritis of the hip joint and undergo to hip replacement surgery with the cementless system corail ¿ pinnacle polyethylene on metal head.The surgery was performed with posterior-lateral approach.Surgeon reamed acetabulum progressively till 52mm, 54 pinnacle with gription coating was impacted.After that the surgeon inserted 3 cancellous 6.5mm screws and apex hole eliminator.Next step was inserting pinnacle marathon liner 54 +4mm with id 36mm.Surgeon noticed mismatch in dimension of the shell and liner.He checked the implants and was noticed the shell was with dimension 52mm od.Due to good primary fixation he decided to leave the implanted shell in place.After that was inserted properly liner 52mm +4mm with 36mm id.Next step was broaching of femur with corail broaches until longitudinal and rotational stability is achieved with size 9.Trial prosthesis was performed with broach in situ and after that was inserted corail std 135 stem size 9 and metal head 36mm - 2.The surgery was extended with 20 min due to mismatch - 121732052 52mm shell was packed in 121732055 54 box.
Additional Manufacturer Narrative
Product complaint # (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: PINN MAR +4 NEUT 36IDX54OD
• 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: 10459728
• Report Number: 1818910-2020-18875
• Device Sequence Number: 19621787
• Product Code: LPH
• UDI-Device Identifier: 10603295014713
• UDI-Public: 10603295014713
• Combination Product (Y/N): N
• Initial Reporter Country: BU
• PMA/510(K) Number: K033273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1219-36-454
• Device Catalogue Number: 121936454
• Device Lot Number: 9329753
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 08/28/2020
• 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: PINN SECTOR W/GRIPTION 54MM
• Patient Age: 72 YR
• Patient Weight: 65