MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 52MM; PROSTHESIS,HIP,SEMICONSTRAINED,UNCEMENTED,METAL/POLYMER,POROUS

Catalog Number	71336452
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one month after surgery, in the review, it was found that one acetabular screw was completely through and out of the acetabular cavity.
Additional Manufacturer Narrative
The associated reflection 3 hole shell was not returned for evaluation.Therefore, a product analysis could not be conducted.However, our investigation indicated that this failure has been previously identified.A quality hold was placed in an attempt to quarantine and re-inspect additional products for this failure mode.During the investigation, it was found that screw hole was damaged during the manual deburr operation.Consequently, corrective actions have been implemented to prevent recurrence of this failure mode.Our clinical evaluation noted that with the limited clinical details, no medical assessment can be rendered at this time.The patient impact beyond the potential screw migration, expected revision procedure/post-op rehab, possible additional radiological exposure and possible continued migration cannot be concluded.Without the return of the actual product involved, 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 the device or additional information be received, the complaint will be reopened.We consider this investigation closed.
Event or Problem Description
It was reported that during the operation, the acetabular screw was through the acetabulum, two screws continuously with the same situation.One month after surgery, in the review, it was found that one acetabular screw was completely through and out of the acetabular cavity.It is considered that the hole dimension of the acetabular is the root cause for the failure of the hip system.

• Brand Name: REF THREE HOLE SHELL 52MM
• Common Device Name: PROSTHESIS,HIP,SEMICONSTRAINED,UNCEMENTED,METAL/POLYMER,POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8064371
• Report Number: 1020279-2018-02443
• Device Sequence Number: 1937663
• Product Code: MBL
• UDI-Device Identifier: 03596010197658
• UDI-Public: 03596010197658
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

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: 71336452
• Device Lot Number: 17GM09503
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 07/11/2019
• 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: 71306812/ 17HM10548; 71333334/ 15BMB0004A; 71336520/ 17HM09021; 76539161/ 17LT95036
• Outcome Attributed to Adverse Event: Other