MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 25MM; PROSTHESIS HIP SEMICONSTRAINED UNCEMENTED METAL/POLY NONPOROUS CALICUMPHOSPHATE

Model Number	71332525
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	01/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation.Stem, head and acetabular liner removed.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to dislocation.Stem, head and acetabular liner removed.The affected complaint devices, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.No medical documents were received for investigation.Thus no thorough investigation could not be performed.Some potential causes could include but are not limited to traumatic injury, surgical technique or abnormal loading of limb.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.

• Brand Name: REF SPHER HEAD SCREW 25MM
• Common Device Name: PROSTHESIS HIP SEMICONSTRAINED UNCEMENTED METAL/POLY NONPOROUS CALICUMPHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8276379
• Report Number: 1020279-2019-00275
• Device Sequence Number: 13973458
• Product Code: MEH
• UDI-Device Identifier: 03596010460462
• UDI-Public: 03596010460462
• Combination Product (Y/N): N
• PMA/510(K) Number: K990666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

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: Other
• Device Model Number: 71332525
• Device Catalogue Number: 71332525
• Device Lot Number: 17GB00042
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 09/30/2020
• 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