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 Break (1069)

Patient Problem No Information (3190)

Event Date 07/26/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to dislocation, and during the revision surgery, the surgeon noticed that a part of the liner had been broken.

Manufacturer Narrative

The associated complaint device was not returned.The clinical/medical team concluded, neither clinical relevant documents, nor the explant will be provided to conduct a thorough medical assessment.Therefore, no medical assessment is warranted at this time.The impact to the patient beyond the revision cannot be concluded.This complaint will be re-evaluated if more information becomes available.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.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• 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: 7805877
• MDR Text Key: 117891935
• Report Number: 1020279-2018-01577
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/02/2018

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: 71337650
• Device Lot Number: 15MM10800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2018
• Initial Date FDA Received: 08/22/2018
• Supplement Dates Manufacturer Received: 07/26/2018
• Supplement Dates FDA Received: 12/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention