MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 45OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number	71324045
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	09/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant was removed.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.The lab analysis concluded, the stem showed signs of bone on/in-growth in the proximal third, porous region on all 4 sides.Scratches on the neck of the stem were visible, likely due to removal.Small scratches observed on the femoral head and outside of bi-polar/liner construct, most likely due to removal.The head is too large to pass through the opening of the bi-polar/liner construct (with applied manual force).The head would need to pass through the opening in order to disassemble.This demonstrates that the head diameter was large enough to be constrained within the bi-polar component, as designed.Retrieved components were disassembled.The locking ring and bi-polar/liner construct were re-examined.No visible deformation or damage on the bi-polar/liner construct, or retainer ring.Scratches were visible on the lateral face of the locking ring, likely due to explant and/or disassembly but no other damage was visible.Dimensional analysis was performed on the locking ring and 3 out of spec dimensions were captured; diameter of thru hole, outside diameter, and groove diameter.No deviations of material or manufacturing process are indicated for these components.The clinical/medical concluded, based on the one undated, unlabeled x-ray that its possible that there was cup as well as femoral stem loosening and the product evaluation that concluded the deviations were likely due to extraction damage, the root cause for the revision cannot be confirmed based solely on the information provided.The future impact of the patient cannot be determined.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Based on this investigation, the need for corrective action is not indicated.This investigation is closed.

• Brand Name: TANDEM INTL BIPOLAR 45OD 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: 8002240
• Report Number: 1020279-2018-02263
• Device Sequence Number: 427377
• Product Code: KWY
• UDI-Device Identifier: 03596010494368
• UDI-Public: 03596010494368
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2019

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: 03/26/2018
• Device Catalogue Number: 71324045
• Device Lot Number: 08CM20623
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 11/27/2018; 11/27/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 12/03/2018; 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention