MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM BIPOLAR COCR 44OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number	71322044
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/29/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed because tandem bipolar component disengaged from shell.
Additional Manufacturer Narrative
The associated complaint devices were returned.A clinical investigation concluded that this complaint reports a revision of a hip secondary to a ¿synergy and bipolar acetabular dislocation¿.Several unsuccessful attempts were made to obtain clinical/medical information.It was communicated that the records were not available.Visual examination of the femoral head revealed marking on the head apex.Examination of tandem bi-polar shell did not reveal any material transfer markings.Witness lines on the id transferred from the backside of the polyethylene liner component were observed.Examination of the rings od sides revealed normal surface witness lines left by the machining process.Examination of the polyethylene liner upper od sides revealed normal witness liners resulting from the machining process.The liner side also revealed indentation marks from being engaged with the locking spikes in the metal shell.The id exhibited some scoring in the bottom.The source could not be determined.The liner did not provide visual evidence of any variation in shape from original form or indicate any deviation from material or process specifications.In conclusion, a root cause for the dislocation cannot be concluded.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal any material or manufacturing deviations that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: TANDEM BIPOLAR COCR 44OD 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: 7095817
• Report Number: 1020279-2017-01198
• Device Sequence Number: 903542
• Product Code: KWY
• UDI-Device Identifier: 03596010492432
• UDI-Public: 03596010492432
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2018

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 Catalogue Number: 71322044
• Device Lot Number: 17HM13731
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 05/03/2018
• 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