MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71335552

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Date 11/07/2019

Event Type  Injury  

Event Description

It was reported that after tha on (b)(6) 2019 the patient was experiencing pain.A linear acetabular loosening was diagnosed.During the revision surgery, a hole change was performed.No patient injury or other complications were reported.

Manufacturer Narrative

The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that this complaint from chili reports the revision of a hip (head, liner and shell) approximately 4 months post implantation, secondary to ¿pain¿ and loosening.No clinical/medical information has been provided for this investigation.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.A review of complaint history did not reveal additional complaints for the listed batches.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 have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Pain is a potential complication associated with any surgery.Some potential probable causes of this event could include patient reaction or a post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: R3 3 HOLE ACET SHELL 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9451741
• MDR Text Key: 170277155
• Report Number: 1020279-2019-04386
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• PMA/PMN Number: K070756
• 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: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71335552
• Device Lot Number: 19CM13385
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention