MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY SO POR PL HA SZ 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71357003
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to stiffness and pain.When the surgeon was inspecting the implants he noticed that the stem was loose.
Additional Manufacturer Narrative
Reviewing the information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The information states that this incident was already reported under the report number 1020279-2019-01670, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to stiffness and pain.When the surgeon was inspecting the implants he noticed that the stem was loose.The affected anthology porous plus offset stem was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.The devices were sterilized according to sterilization release documentation from quality control.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Without the return of the actual product involved and no patient records available, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: ANTHOLOGY SO POR PL HA SZ 3
• 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: 8700941
• Report Number: 1020279-2019-02265
• Device Sequence Number: 19421790
• Product Code: JDI
• UDI-Device Identifier: 03596010559463
• UDI-Public: 03596010559463
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K052792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2019

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: 71357003
• Device Lot Number: 16LM06002A
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 10/29/2019; 10/29/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 11/05/2019; 11/07/2019
• 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: 71330001; 71331954, 71332525, 71335754, 71343603, 71357003; 71331954, 71332525, 71335754, 71343603, 71357003
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention