MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ6 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-01-120

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2019

Event Type  malfunction  

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

It was reported that the package of summit porocoat stem (p/n: 157001120) was mistakenly opened during the fhr surgery of the patient¿s right hip joint with tri-lock stem on (b)(6 2019.Despite checking by a sales-rep, nurses and doctors opened it and realized the mistake when they saw the actual product.Immediately the tri-lock stem which was they were planning to use for the surgery was opened, and the surgery was completed by using the correct stem without a surgical delay.There was no harm to the patient.No further information is available.

Manufacturer Narrative

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: SUMMIT POR TAPER SZ6 STD OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9569927
• MDR Text Key: 189063186
• Report Number: 1818910-2020-01281
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295059370
• UDI-Public: 10603295059370
• Combination Product (y/n): N
• PMA/PMN Number: K001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1570-01-120
• Device Catalogue Number: 157001120
• Device Lot Number: HX3372
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1