MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HD 28 + 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71302804
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 associated complaint device was not returned.The clinical/medical group concluded, 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.Information on the implantation and indication was not provided.Other than the patient age (90 years) and gender (female), no possible contributing factors to a peri-prosthetic fracture were indicated.No fall or specific event causing the fracture was reported.As the fracture occurred a short time after implantation, an intra-operative periprosthetic fracture could have also been unrecognized and simply propagated with progressive weight bearing during the post-operative period.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 part revealed no prior complaints for the listed batch.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: COCR 12/14 FEM HD 28 + 4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7329678
• Report Number: 1020279-2018-00292
• Device Sequence Number: 16530165
• Product Code: LPH
• UDI-Device Identifier: 03596010194138
• UDI-Public: 03596010194138
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2018

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: 71302804
• Device Lot Number: 13MT37873
• 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: 03/10/2018
• Supplement Report FDA Received Date: 06/18/2018
• 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