MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 48OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number	71324048
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was communicated that explants will not be made available for investigation.
Event or Problem Description
It was reported that patient underwent a revision surgery due to acetabular erosion.Surgeon considers this to be not an implant failure but a failure of the patient's anatomy.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Please see attached for investigation results.(b)(4).

• Brand Name: TANDEM INTL BIPOLAR 48OD 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: 6603953
• Report Number: 1020279-2017-00384
• Device Sequence Number: 18989484
• Product Code: KWY
• UDI-Device Identifier: 03596010494399
• UDI-Public: 03596010494399
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2017
• Device Catalogue Number: 71324048
• Device Lot Number: 07JM19266
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: 05/03/2017
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COCR FEM HD GT 28OD +0, 71302800 / 12KT24773
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention