MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 56MM; R3 XLPE LINERS

Catalog Number 71337656

Device Problem Insufficient Information (3190)

Patient Problem Inflammation (1932)

Event Date 01/31/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer indicated that there is no product/device to be returned for investigation analysis.

Event Description

It was reported the subject had tendinitis and was treated with medication.

Manufacturer Narrative

The associated complaint devices were not returned for evaluation.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.Without the actual products involved, our investigation cannot proceed.If the devices or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: R3 20 DEG XLPE ACET LNR 32MM X 56MM
• Type of Device: R3 XLPE LINERS
• 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: yagna angirish ; 1450 brooks rd; memphis, TN 38116 ; 9013995009
• MDR Report Key: 5591321
• MDR Text Key: 43107112
• Report Number: 1020279-2016-00340
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/23/2020
• Device Catalogue Number: 71337656
• Device Lot Number: 10GM14316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2010
• 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
• Treatment: (B)(4)
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 82