MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG ORTHOPAEDIC RECONSTRUCTION DEV; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 01/01/2014

Event Type  Injury  

Event Description

Literature case "risk factors for periprosthetic femur fracture and influence of femoral fixation using the mini-anterolateral approach in primary total hip arthroplasty".Author: carl l.Herndon, md et al., the journal of arthroplasty.There were 684 primary thas in this study, 57 (8.3%) pffs (periprosthetic femur fracture) occurred.It was documented on the paper that there were 12 pffs in patients with smith & nephew uncollared polar stem.

Manufacturer Narrative

The study of herndon et.Al.[1] reports surgeries on 684 hips.It is reported that in 12 cases patients suffered from a periprosthetic fracture.In all cases an uncollared polarstem was implanted.The part and the batch number of the devices, used in treatment, are not known.Therefore, the batch record review and a complaint history review could not be performed.The reported failure mode might occur in some cases, which is stated as a side effect in the ifu (lit.No.12.23 ed.05/16).The severity and the failure mode are covered through the risk management.As no device was received for investigation, a visual inspection could not be performed.No patient specific information nor any other medication documentation was provided, therefore, a thorough medical investigation could not be performed.Based on the conducted investigation the failure mode cannot be confirmed and the root cause of the reported issue stays undetermined due to insufficient information.To date, no further actions are deemed necessary.Smith and nephew will monitor the devices for further similar issues.[1]: herndon, carl l, jared a nowell, nana o sarpong, h.John cooper, roshan p shah, and jeffrey a geller.The journal of arthroplasty 35.3 (2020): 774-78.

• Brand Name: ORTHOPAEDIC RECONSTRUCTION DEV
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10138691
• MDR Text Key: 194657329
• Report Number: 9613369-2020-00111
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention