MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR PLUS HA HO STEM SZ 13; PROSTHSISHIP,SMICONSTRAIND,UNCMNTD,MTAL/POLYMR,NON-POROUS, CALICUM-PHOSPHATE

Model Number	71309113
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery on the left hip was performed due to pain on movement.An xray showed lysis around the femoral stem.The syn por plus ha ho stem sz 13 was found to be loose and was removed.It had visible signs of wear on the proximal shoulder.A reflection liner was also removed and showed signs of wear: so a new liner was implanted.The oxinium head was also explanted but there is not apparent failure in the head.
Additional Manufacturer Narrative
It was reported that a revision surgery on the left hip was performed due to pain on movement, an xray showed lysis around the femoral stem.The synergy stem was found to be loose and was removed; it had visible signs of wear on the proximal shoulder.The reflection liner was removed and showed signs of wear: so a new liner was implanted.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.A review of the manufacturing records for the listed batch 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.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.The device was implanted in 2003.The surgeon doesn¿t fault the product.Possible cause could include but is not limited to lifetime of device.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: SYN POR PLUS HA HO STEM SZ 13
• Common Device Name: PROSTHSISHIP,SMICONSTRAIND,UNCMNTD,MTAL/POLYMR,NON-POROUS, CALICUM-PHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10084646
• Report Number: 1020279-2020-01851
• Device Sequence Number: 11586500
• Product Code: MEH
• UDI-Device Identifier: 03596010459787
• UDI-Public: 3596010459787
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2020

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: 71309113
• Device Lot Number: 03CM01745
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/01/2020
• Initial Date Received by Manufacturer: 05/01/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 05/23/2020
• Supplement Report FDA Received Date: 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71342804/OXINIUM FEM HD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention