MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 48OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number	71324048
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to patient presented in er with dislocation after sitting down with legs crossed.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted the root cause of the dislocation is the crossing of the legs which is contraindicated post op hip surgery.The impact on the patient beyond revision surgery is undetermined.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re opened.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Proceed based on information provided and/or available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by dr.(b)(6) and/or (b)(6), medical director.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information.Surgical procedure/post-operative care review.Device labeling (including technique guides, ifus, etc).It was reported that a revision was performed due to dislocation of hip approximately one month post hip surgery implantation after crossing legs.Crossing legs post hip surgery is contraindicated in the healing process.An x-ray has been submitted and does not show a reason for the dislocation and its presumed that it¿s for the left side as that¿s the side that has the reported tandem bipolar head.However, there is no further other supporting documentation to include in this clinical assessment.In conclusion: the root cause of the dislocation is the crossing of the legs which is contraindicated post op hip surgery.The impact on the patient beyond revision surgery is undetermined.In conclusion: the root cause of the dislocation is the crossing of the legs which is contraindicated post op hip surgery.The impact on the patient beyond revision surgery is undetermined.

• Brand Name: TANDEM INTL BIPOLAR 48OD 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: 8476148
• Report Number: 1020279-2019-01338
• Device Sequence Number: 13831735
• Product Code: KWY
• UDI-Device Identifier: 03596010494399
• UDI-Public: 03596010494399
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2019

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: 71324048
• Device Lot Number: 18BW00002
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 11/17/2019
• 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
• Patient Weight: 54