MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 32MM X 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71339548

Device Problem Insufficient Information (3190)

Patient Problem Joint Dislocation (2374)

Event Date 11/03/2017

Event Type  Injury  

Event Description

It was reported that a surgical intervention was performed due to dislocation, all parts were removed.

Manufacturer Narrative

The associated complaint device was not returned.A clinical analysis indicated that it was reported this patient returned to the hospital due to dislocations.All parts were removed and a liner was cemented in.However, no clinically supporting documentation has been provided for inclusion in this investigation.Without the explant, or the requested clinical information the root cause of the dislocation cannot be determined.The impact to the patient beyond the dislocations cannot be concluded.No further clinical/medical assessment is warranted at this time.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.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: R3 0 DEG XLPE ACET LNR 32MM X 48MM
• 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
• MDR Report Key: 7140321
• MDR Text Key: 95581270
• Report Number: 1020279-2017-01331
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598790
• UDI-Public: 03596010598790
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71339548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention