MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNEE NAIL GOLD 10X38 RETRO/TIB; NAIL, FIXATION, BONE

Model Number	71633238
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Neovascularization (1978)
Date of Event	04/14/2008
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a left hip revision surgery due to acetabular fracture.Patient developed avascular necrosis of his femoral head with post-traumatic arthritis.
Additional Manufacturer Narrative
The devices, used in treatment were not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and confirms the root cause of the avascular necrosis of his femoral head with subsequent posttraumatic arthritis cannot, definitively be concluded.It is unknown what the trauma of the mva just 9 months previously may have contributed.Although elevated cobalt levels, migration and lucency around the cup from radiological studies and loosening, as well as milky material from the hip joint and flocculent debris are consistent with findings associated with metallosis; without the radiology images and the return of the implant it cannot be confirmed.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.Factors and/or some potential probable causes that could contribute to the reported event include but not limited to traumatic injury and overuse.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.

• Brand Name: KNEE NAIL GOLD 10X38 RETRO/TIB
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9217844
• Report Number: 1020279-2019-03700
• Device Sequence Number: 13994908
• Product Code: JDS
• UDI-Device Identifier: 03596010410153
• UDI-Public: 03596010410153
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K981529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2020

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: 07/08/2017
• Device Model Number: 71633238
• Device Catalogue Number: 71633238
• Device Lot Number: 07GM07279
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 08/11/2020
• 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