MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY SO POROUS SZ 11; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71356011
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Note: implanted date, is an approximate.
Event or Problem Description
It was reported that a revision surgery has been scheduled due to stem loosening of right hip with progressive limp, pain and shortening of right hip and leg.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Our investigation included a review of the manufacturing records for the listed batches which did not reveal any deviation from the standard manufacturing processes.A clinical evaluation performed in this investigation noted that all documents provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.Based on the provided information, it was concluded that repeated trauma on the right side was likely the contributing factors to the stem subsidence and/or loosening and reported right tha revision/ae#5.The patient impact beyond the revision procedure cannot be determined.No further medical assessment is warranted at this time.Without the return of the actual product involved, 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.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: ANTHOLOGY SO POROUS SZ 11
• 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: 7215751
• Report Number: 1020279-2018-00074
• Device Sequence Number: 164879
• Product Code: JDI
• UDI-Device Identifier: 03596010567819
• UDI-Public: 03596010567819
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K052792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2018

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 Expiration Date: 01/20/2019
• Device Catalogue Number: 71356011
• Device Lot Number: 08MM19230A
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/26/2017
• Supplement Date Received by Manufacturer: 12/26/2017
• Initial Report FDA Received Date: 01/24/2018
• Supplement Report FDA Received Date: 05/10/2018
• 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: Other; Required Intervention
• Patient Weight: 103