MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-01-054

Device Problems Contamination /Decontamination Problem (2895); Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Code Available (3191)

Event Date 01/22/2020

Event Type  malfunction  

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 Description

Customer is complaining about the sterile package of product.The cover was not possible to be removed properly.Another product was available and used without issues.No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned package confirms the reported observation.The root cause could not be determined.A review of the device manufacturing records found no deviations or anomalies.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, 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.Device history lot: lot 9330519.Review of the device manufacturing record found no related deviations or anomalies.Device history review: review of the device manufacturing record found no related deviations or anomalies.

• Brand Name: PINNACLE 100 ACET CUP 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: 9717421
• MDR Text Key: 189873212
• Report Number: 1818910-2020-05034
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295008569
• UDI-Public: 10603295008569
• Combination Product (y/n): N
• PMA/PMN Number: K000306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1217-01-054
• Device Catalogue Number: 121701054
• Device Lot Number: 9330519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1