MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 60MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-22-060

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 05/30/2022

Event Type  malfunction  

Event Description

It was reported that operating room staff collected an implant box they've removed the plastic but the implant included in the box was the wrong implant.They have tried to implant this item in the patient, but it was impossible.They've opened a new implant and finished the surgery.There was a 10 minute surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional information received indicated that there was no surgical delay.

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:  added: a2 (age), a3, b5, h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: e1 (facility name), h8.

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 #
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> pc-(b)(4).Investigation summary
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> the device associated with this report was received for examination.Visual examination of the returned package confirmed that product returned did not correspond to the package product's identification label.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot
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> a manufacturing record evaluation was performed for the finished device (121730064 /677199) product and lot numbers, and no non-conformances were identified.Device history review
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> a manufacturing record evaluation was performed for the finished device (121730064 /677199) product and lot numbers, and no non-conformances were identified.Corrected: h3.

• Brand Name: PINNACLE SECTOR II CUP 60MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14685716
• MDR Text Key: 293942567
• Report Number: 1818910-2022-10840
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295009863
• UDI-Public: 10603295009863
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/14/2022

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
• Device Operator: Health Professional
• Device Model Number: 1217-22-060
• Device Catalogue Number: 121722060
• Device Lot Number: 9164629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2022
• Initial Date FDA Received: 06/14/2022
• Supplement Dates Manufacturer Received: 06/15/2022; 07/08/2022; 03/03/2023
• Supplement Dates FDA Received: 06/17/2022; 07/12/2022; 03/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Male