MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN R3 SHELL; PRSTHSS, HP, HM-, TRNNN-BRNG, FMRL, MTL/PLYCTL

Catalog Number 71342204

Device Problem Connection Problem (2900)

Patient Problem Joint Dislocation (2374)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case- (b)(4).

Event Description

It was reported that, the constrained liner r3 const 54mm (case-(b)(4)) disassociated from the r3 shell (case-(b)(4)) so a revision surgery was performed.Patient was revised to or30 smith and nephew dual mobility system.No delay was reported.No other complications were reported.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.The lab analysis concluded that the oxinium head showed scratches on the underside upon the lower lip edge that may have been caused by extraction.The embedded oxinium head was observed to be tight inside the liner.The liner also showed small pits and scratches that may have been caused by extraction as well.The absence of laser marking on the polymer top edge combined with the loosening of the detached ring, suggests the entire assembly has been autoclaved which can cause the laser marks on the polymer to disappear as well as account for the tight interface between the oxinium head and the liner.No further investigation is possible as it is impossible to know the original state of the devices before autoclaving.The clinical/medical evaluation concluded that the complaint was re-assessed due to the return of the s&n product.Based on the information provided, the product evaluation, revealed there were no manufacturing abnormalities that could have contributed to the reported failure.It was communicated that the requested medical documentation was not available for inclusion in the medical investigation.Therefore, we are currently unable to rule out a procedural variance as a contributing factor to the reported failure, which does not represent a device malfunction.Without additional relevant clinical information, the previous assessment of the revision approximately 5 months post implantation due to disassociation of the constrained liner from the r3 shell remains unchanged.Since there were no delays or other complications reported.The impact to the patient beyond the reported disassociation and subsequent revision could not be determined.No further medical assessment could be rendered at this time.Should any additional relevant medical information be provided, this complaint would be re-assessed.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.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Possible causes could include but not limited to traumatic injury, surgical technique or size of device.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: UNKNOWN R3 SHELL
• Type of Device: PRSTHSS, HP, HM-, TRNNN-BRNG, FMRL, MTL/PLYCTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11123639
• MDR Text Key: 225284998
• Report Number: 1020279-2021-00122
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71342204
• Device Lot Number: 20EM03670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR