MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 26 0 DEG 54-56 SZ F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71333365
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation.Devices explanted: reflextion xlpe 26 0 degrees 54-56 size f (71333365), univ cobalt chrome 10/12 taper fem hd 26mm 0 ext (11910), synergy select poras stem size 14 (71305014) and reflection fso shell v 56mm (71330056).Devices implanted: ox head and reflexion liner.Pre-existing conditions: osteoarthritis.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to dislocation.Devices explanted.The associated reflection microstable acetabular liner, universal cobalt chrome femoral head, synergy porous standard offset and reflection acetabular shell, used in treatment, were not returned for evaluation.Smith and nephew has been unable to obtain device details.As device information was not made available, device history record review cannot be completed.There is no information that would suggest the devices failed to meet specifications.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode.The lot is unknown for these parts.A relationship, if any, between the devices 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.The doctor believes the products are not defective.Also he believes this revision case is caused by oa because of aging.Probable causes could include but not limited to patient anatomy or limited range of motion.Without the return of the actual products involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: REF XLPE 26 0 DEG 54-56 SZ F
• 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: 9216050
• Report Number: 1020279-2019-03687
• Device Sequence Number: 11383796
• Product Code: LPH
• UDI-Device Identifier: 03596010455833
• UDI-Public: 03596010455833
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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: 71333365
• Device Catalogue Number: 71333365
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 02/12/2020
• 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: P# 71305014 SYN SEL POR SO 10/12 TPR SZ 14; P# 71330056 REF FSO 5 56MM OD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR