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

Catalog Number	71324044
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	11/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a hip revision was performed on a patient after primary spectron/tandem hip done, two weeks prior.The tandem and cocr femoral head was extracted and replaced by a r3 three-hole cup with constrained liner and 22mm cocr femoral head.The patient dislocated after the primary surgery due to contractions ¿ she is spastic.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A visual examination of the as- received components indicated minor scratches were seen on the femoral head and rim of the tandem shell and liner; this was likely due to removal of the implants.No damage was observed on the outer diameter of the tandem shell or of the femoral head.According to the complaint description, dislocation was likely a patient specific failure and not an implant failure.No material or manufacturing deviations were identified during this investigation.A clinical analysis indicated that based on the limited information provided, the revision was due to the reported dislocation secondary the patient¿s to contractions/spasticity and not an implant failure.The patient impact was the dislocation, subsequent revision procedure and a post-surgical convalescence phase; however, future complications cannot be ruled out due to the patient¿s existing dementia and spasticity.No further medical assessment can be rendered at this time.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.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.

• Brand Name: TANDEM INTL BIPOLAR 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: 8102238
• Report Number: 1020279-2018-02569
• Device Sequence Number: 16577878
• Product Code: KWY
• UDI-Device Identifier: 03596010494351
• UDI-Public: 03596010494351
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

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 Catalogue Number: 71324044
• Device Lot Number: 17JW05555A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 12/20/2019
• 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