MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71335752

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Joint Dislocation (2374)

Event Date 01/19/2018

Event Type  Injury  

Event Description

Patient positioned and hip dislocated.Liner and screws removed cup was loose.Removed cup reamed acetabulum and implanted a 52mm multihole cup and three screws.A constrained liner inserted and checked to be locked in the cup.Hip reduced using a 22mm stryker head.Hip stable.

Manufacturer Narrative

The associated complaint device was not returned for evaluation the associated r3 3hole acetabular shell, r3 acetabular liner, head screws and hole cover were not returned for evaluation.A review of complaint history on the listed parts revealed no additional complaints for this issue with the same batch number.Our investigation included a review of the manufacturing records which did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A clinical evaluation noted that based on the available information, the root cause of the ¿cup loosening¿ cannot be concluded.It is unknown if the post-primary surgery fall contributed to the ¿loosening¿ but that explanation cannot be excluded.Without the return of the actual product involved, our investigation is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: R3 20 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7262494
• MDR Text Key: 99762842
• Report Number: 1020279-2018-00151
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598332
• UDI-Public: 03596010598332
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 71335752
• Device Lot Number: 17GM12373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 150