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

Catalog Number 71337650

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Failure of Implant (1924); Pain (1994); Discomfort (2330); Injury (2348)

Event Date 11/01/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed to exchange liner due to it was loose and not properly fixed into the cup causing pain and discomfort to patient.

Manufacturer Narrative

The associated complaint device was returned and evaluated.The lab analysis concluded, the retrieved component is shown in.Damage was observed on all the locking tabs as shown in.Scratches and gouges were seen on the inner diameter, the rim of the liner, and on the splines of the outer diameter as shown in.A crack was observed on the inner rim of the liner as shown in.The damage to the liner was likely caused when it became loose in vivo or during removal.Dimensional analysis revealed dimensions out of specification, but all the measureable dimensions were noted as damaged.This is likely due to the damage the liner endured in vivo.No material or manufacturing deviations were identified during this investigation.The cause of the liner loosening is unknown.Dimensional inspection was performed on the liner.Significant extraction damage was noted on the id and od, especially across the face and splines.Part was too damaged to be analyzed on cmm.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.The clinical/medical team concluded, although the lab retrieval analysis reported all measurable dimensions were damaged, no material or manufacturing deviations were noted and the cause of the liner loosening was unknown.No clinically relevant supporting documentation was provided; however, based on the disassociation of the liner within 2-3 weeks of implantation is suspicious for inadequate primary seating of the liner or a traumatic event as possible contributing factors to the reported loosening.The patient impact beyond the reported pain/discomfort, revision surgery and an expected post-operative rehabilitation phase cannot be concluded.Should additional information become available, the clinical/medical assessment may be re-evaluated.

• Brand Name: R3 20 DEG XLPE ACET LNR 32MM X 50MM
• 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: 8115192
• MDR Text Key: 128745857
• Report Number: 1020279-2018-02631
• Device Sequence Number: 1
• Product Code: MBL
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71337650
• Device Lot Number: 18AM02309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Date Manufacturer Received: 11/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention