MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 32MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 71339552

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/30/2020

Event Type  Injury  

Event Description

It was reported that during a thr procedure whilst impacting the inlay, it was not possible to fix the inlay in the cup.The inlay was discarded and thrown away in the clinic.A second inlay had to be opened.It was only possible to fix the inlay in the cup with extremely high force.There was surgical delay of 10 minutes without impact known.

Manufacturer Narrative

It was reported that during a thr procedure whilst impacting the inlay, it was not possible to fix the inlay in the cup.The inlay was discarded and thrown away in the clinic.A second inlay had to be opened.It was only possible to fix the inlay in the cup with extremely high force.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device batch information was not made available, device history record review cannot be completed.Therefore, the device manufacturing date is unknown.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.A review of risk management files and instructions for use found that the reported failure was documented appropriately.A clinical analysis noted that the provided post-op images do not provide insight into the root cause of the reported intraoperative event.No further medical documentation has been provided for inclusion in the medical investigation.Based on this investigation, the need for corrective action is not indicated.Some potential causes could include but are not limited to surgical technique used or user/procedural variance.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: R3 0 DEG XLPE ACET LNR 32MM X 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10353269
• MDR Text Key: 201337328
• Report Number: 1020279-2020-03609
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71339552
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 09/21/2020
• Supplement Dates FDA Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention