MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP IMPLANT; PRSTHSS, HP, HM-, TRNNN-BRNG, FMORL, MTL/PLYCTL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 01/14/2020

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed to change of inlay from size 62 mm/36 to 60 mm/36, probably due to previous implantation of an inlay with the wrong size.

Manufacturer Narrative

It was reported that a revision surgery was performed to change of inlay from size 62 mm to 60 mm, probably due to previous implantation of an inlay with the wrong size.The affected r3 articular liner, used in treatment, was not returned for evaluation.However, a picture of labels was submitted which showed the sizes are readable with little effort.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.No relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.The reported failure has been noted on the instructions for use and on the risk management files.Based on this investigation, the need for corrective action is not indicated.Some potential causes could include but are not limited to user error or labeling issue.It was communicated that the wrong size was implanted and not noticed intraoperatively as the insert initially jammed well and seemed to be firmly fixed.

• Brand Name: HIP IMPLANT
• Type of Device: PRSTHSS, HP, HM-, TRNNN-BRNG, FMORL, MTL/PLYCTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9609365
• MDR Text Key: 175847021
• Report Number: 1020279-2020-00342
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention