MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM BIPOLAR COCR 47OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number	71322047
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tandem from 2016 with a recall, was implanted in a patient.
Additional Manufacturer Narrative
The associated complaint device was not returned.Per our field action team, the recall was issued back in 2016 for the product in this complaint.Per the communication sent, there was no answer from this facility.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: TANDEM BIPOLAR COCR 47OD 28ID
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8262911
• Report Number: 1020279-2019-00209
• Device Sequence Number: 18867286
• Product Code: KWY
• UDI-Device Identifier: 03596010492463
• UDI-Public: 03596010492463
• Combination Product (Y/N): N
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2023
• Device Catalogue Number: 71322047
• Device Lot Number: 13MM09529
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: R-2016-32
• Patient Sequence Number: 1