MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-32-054

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Patient code: no code available ((b)(4)) used to capture insufficient information; not applicable ((b)(4).) used to capture surgery prolonged and no information available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event 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 with ref (b)(4) /lot9205498 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.

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.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received.Affected side of the patient is right hip.

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.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : no device or packaging materials associated with the acetabular cup have been returned for examination.A review of the device manufacturing records finds no related anomalies or deviation.There is no evidence of a processing error by depuy.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.

• Brand Name: PINN SECTOR W/GRIPTION 54MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10304660
• MDR Text Key: 229284295
• Report Number: 1818910-2020-16453
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295010319
• UDI-Public: 10603295010319
• Combination Product (y/n): N
• PMA/PMN Number: K071784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1217-32-054
• Device Catalogue Number: 121732054
• Device Lot Number: 9205498
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PINN MAR +4 NEUT 36IDX54OD
• Patient Age: 72 YR
• Patient Weight: 65