MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIV FEM HEAD COC 26MM 0 EXT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	11910
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	01/31/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to pain, fever, swelling, and fracture.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.A review of the device history records for the listed batches did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the risk management file and instructions for use document for this failure mode was conducted and concluded this failure mode has been identified.Our clinical/medical team concluded: it was reported that revision surgery was performed 3 weeks post implantation, due to pain, fever, swelling, and fracture.It was additionally reported that the fracture was seen during the initial surgery.It was communicated via email that no medical records or x-rays will be provided, and the explanted devices will not be returned for analysis.Therefore, a clinical assessment cannot be performed and the patient impact beyond the revision surgery cannot be concluded.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNIV FEM HEAD COC 26MM 0 EXT
• 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: 9687250
• Report Number: 1020279-2020-00502
• Device Sequence Number: 13544688
• Product Code: LPH
• UDI-Device Identifier: 00885556008775
• UDI-Public: 00885556008775
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020

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: Health Professional
• Device Model Number: 11910
• Device Catalogue Number: 11910
• Device Lot Number: 19KM16886
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 10/30/2020
• 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