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

Catalog Number 71324048

Device Problem Material Erosion (1214)

Patient Problem No Code Available (3191)

Event Date 05/03/2017

Event Type  Injury  

Manufacturer Narrative

It was communicated that explants will not be made available for investigation.

Event 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.

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
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• 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 ; schachenallee 29; aarau 05001 ; SZ 05001
• MDR Report Key: 6603953
• MDR Text Key: 76370631
• Report Number: 1020279-2017-00384
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 03596010494399
• UDI-Public: 03596010494399
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K023743
• 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: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2017
• Device Catalogue Number: 71324048
• Device Lot Number: 07JM19266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2007
• 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: COCR FEM HD GT 28OD +0, 71302800 / 12KT24773
• Patient Outcome(s): Hospitalization; Required Intervention