MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF ALL POLY 32ID 58OD XLPE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71358037
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed due patient implant dislocation.Replaced with constrained liner.
Additional Manufacturer Narrative
The associated reflection all poly was returned and evaluated.A lab analysis conducted during this investigation indicated that damage was observed on the superior face of the component which was likely due to contact with an instrument during removal.No damage was observed on the articulating surface.Pmma pods were not found on the received component.No material or manufacturing deviations were observed.No destructive testing was performed on this retrieved component.The batch number on the part was illegible.Thus, a review of the manufacturing records could not be performed.Complaint history review could not be performed with any accuracy due to the lack of clear batch number.A clinical evaluation noted that based on the single x-ray provided, the femoral head could have been dislocated from the constrained poly liner.In addition, there was significant osteolysis around the acetabular cup.However, due to the limited information provided the root cause of the reported dislocation cannot be determined.However, based on the e-mails from the smith and nephew sales rep the dislocation was not due to a failure of the implant device.The future impact to the patient beyond the revision cannot be determined.No further clinical/medical assessment is warranted at this time.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, this complaint will be reopened and reevaluated.

• Brand Name: REF ALL POLY 32ID 58OD XLPE
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8268763
• Report Number: 1020279-2019-00242
• Device Sequence Number: 2370275
• Product Code: JDI
• UDI-Device Identifier: 03596010474278
• UDI-Public: 03596010474278
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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: 71358037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 05/15/2019
• 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 Age: 85 YR