MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY STD BROACH SIZE 6; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71365606
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery the surgeon broached up to a 6 anthology and when the stem was implanted it sunk beyond where the broach sat.A s&n higher size stem was used to complete the procedure.No delay or injury reported.
Additional Manufacturer Narrative
The associated devices were returned and evaluated.A visual inspection of the returned devices could not confirm the stated failure mode.The stem has some stains and scratches from the attempted insertion.The broach is very worn with many nicks and gouges in the cutting teeth.The devices were manufactured in 20005 and 2019.A dimensional inspection confirmed that the broach was oversized.The dimensional inspection found the stem to be within specification.This failure was evaluated through our internal quality hold process and was found to be isolated.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.
Additional Manufacturer Narrative
The associated devices, used in treatment, were returned and evaluated.A visual inspection of the returned devices could not confirm the stated failure mode.The stem has some stains and scratches from the attempted insertion.The broach is very worn with many nicks and gouges in the cutting teeth.The devices were manufactured in 20005 and 2019.A dimensional inspection confirmed that the broach was oversized.A dimensional inspection found the stem to be within specification.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have reason to suspect that the product failed to meet product specifications at the time of manufacture.The likely probable cause of this event is a manufacturing process error.This failure was evaluated for potential corrective action and was found to be isolated at this time.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: ANTHOLOGY STD BROACH SIZE 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: 9258621
• Report Number: 1020279-2019-03853
• Device Sequence Number: 2288780
• Product Code: JDI
• UDI-Device Identifier: 03596010560018
• UDI-Public: 03596010560018
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2020

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 Model Number: 71365606
• Device Catalogue Number: 71365606
• Device Lot Number: 05JM12122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 11/19/2019; 03/13/2020
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 03/05/2020; 03/16/2020
• 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