MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 71337650

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/12/2021

Event Type  malfunction  

Event Description

It was reported that, during thr surgery, an r3 20 deg xlpe acet lnr 32mm x 50mm couldn't be locked after trying several times.The procedure was completed using a s+n back-up device.The event resulted in an unplanned increase of 10 minutes of surgery time, increased the patient's blood loss and risk of infection.Patient was not harmed.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device has signs of damage from the attempted insertion.The returned part was evaluated for critical to quality features.All measured features are within tolerance per associated drawing print.At this point, the cause of the complaint cannot be contributed to the dimensions of the returned product.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: R3 20 DEG XLPE ACET LNR 32MM X 50MM
• 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: 12077050
• MDR Text Key: 258694305
• Report Number: 1020279-2021-05477
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010598486
• UDI-Public: 03596010598486
• Combination Product (y/n): N
• PMA/PMN Number: K113848
• 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: 09/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71337650
• Device Catalogue Number: 71337650
• Device Lot Number: 19MM04447
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1