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

Catalog Number	71356111
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed and all components were removed due to a fractured stem.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, approximately 3 years and 3 months post implantation thr a patient underwent revision hip surgery and again 14 months later.Index operative notes were provided as well as operative notes for the two revision procedures.The patient presented with bone spurs and severe osteoarthritis.During the first revision it was found that the right leg was found to be shorter than the left.The acetabulum and anterior lip liner showed retroversion.There was also slight bone loss noted.With the second revision it was noted that fluid was sent for analysis.There was a fractured neck of the previous femoral stem found.Osteotomy had to be performed after an hour of attempting to loosen the implant.The root cause of the first revision was likely the reported retroversion of the acetabulum and resulting psoas impingement.The second revision was performed to revise the broken femoral stem but a root cause of this fractured stem cannot be concluded based on the information provided.The impact to the patient beyond pain, elevated white count from sample of synovial fluid and two revision procedures is unknown.Without x-rays or more specific information regarding comorbidity, possible trauma, and other patient medical history; no further clinical/ medical investigation can be rendered at this time.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 parts revealed no prior complaints for the listed batches.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 HO 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: 8634422
• Report Number: 1020279-2019-02028
• Device Sequence Number: 2005751
• Product Code: JDI
• UDI-Device Identifier: 03596010567932
• UDI-Public: 03596010567932
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• 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: 03/25/2019
• Device Catalogue Number: 71356111
• Device Lot Number: 09CM20810
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PART NUMBER 71332515 / LOT NUMBER UNKNOWN; PART NUMBER 71332520 / LOT NUMBER UNKNOWN; PART NUMBER 71332525 / LOT NUMBER UNKNOWN; PART NUMBER 71332540 / LOT NUMBER UNKNOWN; PART NUMBER 71332766 / LOT NUMBER UNKNOWN; PART NUMBER 71338674 / LOT NUMBER UNKNOWN; PART NUMBER 71343612 / LOT NUMBER UNKNOWN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR