MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 52MM; PRSTHSS,HP,SMCNSTRND,UNCMNTD,MTALPLYMR,PRS

Catalog Number	71336452
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the implantation of the device, the nails penetrated into the cup and this caused anatomical penetration to the pelvis.A delay greater than 2 hours was reported due to this issue.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.Visual examination of the returned shell did not exhibit damage to the porous coated or id side of the shell.Damage to one of the three screw holes was found.Dimensional examinations of the component revealed dimension deviations relative to the two undamaged screw holes.No other issues relative to material or manufacturing processes were noted.A dimensional indicated that one of the screw holes was found to be damaged at receipt so it could not be measured accurately.The other two holes were found to not meet the print specification.A review of complaint history did not reveal additional complaints for the listed batch.A clinical analysis concluded that it appears that the reason the screw went through the cup could be manufacturing related but the impact to the patient cannot be concluded beyond the extended surgical time to retrieve the screw as images to support where the screw went through to the pelvis and if it went deeper.No further assessment is able to be performed.A quality hold was placed in an attempt to quarantine and re-inspect additional product for this failure mode.This issue has also been communicated to our management process for their consideration of further action.We will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: REF THREE HOLE SHELL 52MM
• Common Device Name: PRSTHSS,HP,SMCNSTRND,UNCMNTD,MTALPLYMR,PRS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7507230
• Report Number: 1020279-2018-00909
• Device Sequence Number: 19221400
• Product Code: MBL
• UDI-Device Identifier: 03596010454355
• UDI-Public: 03596010454355
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K960094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2018

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 Catalogue Number: 71336452
• Device Lot Number: 17DM05655
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 11/13/2018
• 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 Age: 52 YR