MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 54OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number	71324054
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Stem subsidence owing to fracture at calcar and greater trochanter surgeon dissected down to hip joint.Dislocated hip.Removed stem and bipolar head as one construct using the polarstem removal tool prepared canal for echelon cemented stem cemented size 14 175mm echelon stem std collar.Trialed bipolar head and hip deemed stable.Inserted definitive bipolar construct onto stem.Reduced hip.Reduced gt fracture and fixated with periprosthetic plate.
Additional Manufacturer Narrative
The affected tandem intl cocr shell liner bipolar was not returned for evaluation.A clinical evaluation noted the provided image of an x-ray pelvic overview, dated 3 days before the revision and 2 weeks after implantation, shows the mentioned calcar fracture.As no immediate post-operative x-rays is available for comparison, the subsidence cannot be further described.As the fracture occurred a short time after implantation, an intra-operative peri-prosthetic fracture could have also been unrecognized and simply propagated with progressive weight bearing during the post-operative period.Based on the performed investigation the root cause of the reported of the reported event cannot be determined.A review of the production documentation for the corresponding product did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual product involved, our investigation of this report is inconclusive.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: TANDEM INTL BIPOLAR 54OD 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: 7329703
• Report Number: 1020279-2018-00291
• Device Sequence Number: 16172967
• Product Code: KWY
• UDI-Device Identifier: 03596010494450
• UDI-Public: 03596010494450
• Combination Product (Y/N): N
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2018

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: Lay User/Patient
• Device Expiration Date: 08/08/2026
• Device Catalogue Number: 71324054
• Device Lot Number: 16HM06533
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2018
• Supplement Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 03/11/2018
• Supplement Report FDA Received Date: 06/20/2018
• 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