MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY SO POR PL HA SZ 6; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71357006
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/23/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a total hip arthroplasty on (b)(6) 2013 and 2 months later, the stem was confirmed which had subsided.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, (b)(6) based on the limited information provided and without the return of the device for evaluation the root cause of the reported component subsidence cannot be determined.(b)(6) the lack of bone ingrowth on the proximal aspect of the stem would allow for migration which over time would put fatigue on the stem causing the fracture.However based on the limited information and without the return of the device for evaluation the root cause of the fractured femoral prosthetic stem cannot be determined.The future impact to the patient beyond the revisions cannot be determined.No further clinical assessment is warranted.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: ANTHOLOGY SO POR PL HA SZ 6
• 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: 8634428
• Report Number: 1020279-2019-02032
• Device Sequence Number: 11248267
• Product Code: JDI
• UDI-Device Identifier: 03596010559494
• UDI-Public: 03596010559494
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2019

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 Expiration Date: 10/06/2023
• Device Catalogue Number: 71357006
• Device Lot Number: 13FM08121
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 10/22/2019
• 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: 61 YR