MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71332752

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 02/01/2019

Event Type  Injury  

Event Description

It was reported that a revision was performed due to recurrent dislocation and instability.

Manufacturer Narrative

A clinical evaluation was conducted and it has been communicated that no clinical documents are available.Therefore, no thorough clinical assessment of the reported issue can be rendered.Should additional information be provided, the clinical/medical investigation task will be reopened.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re opened.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Will proceed with a medical assessment based on clinical supporting documents provided.If no relevant medical information is provided can close the mi task.Approved by (b)(6) md.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information.Surgical procedure/post-operative care review.Device labeling (including technique guides, ifus, etc.) it has been communicated that no clinical documents are available.Therefore, no thorough clinical assessment of the reported issue can be rendered.Should additional information be provided, the clinical/medical investigation task will be reopened.

• Brand Name: R3 0 DEG XLPE ACET LNR 36MM X 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: 8365006
• MDR Text Key: 136973177
• Report Number: 1020279-2019-00784
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010597984
• UDI-Public: 03596010597984
• 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: 06/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71332752
• Device Lot Number: 18HM13992A
• Date Manufacturer Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention