MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL MM48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71335548
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, shell let the screw go all the way through.Surgeon was able to remove all and another smith and nephew cup and screw were used.Backup devices were the same size as the original implants.No injury reported.A slight delay while getting the original implants out of the patient reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.One of the holes has damaged from attempted insertion.The hole seems to be nicked by the screw.A dimensional analysis was completed on the returned r3 3 hole acetabular shell device.Visually, the 40 degree hole has visible damage from attempted implantation around the counterbore spotface.Each of the three screw holes was inspected with attribute plug gage p-723-012.Each screw hole successfully passed the go member and failed to accept the no-go member, including the damaged 40 degree hole.The failure mode cannot be confirmed via dimensional analysis of the returned device.A review of complaint history did not reveal additional complaints for the listed batch.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 do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.

• Brand Name: R3 3 HOLE ACET SHELL MM48
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10461352
• Report Number: 1020279-2020-04255
• Device Sequence Number: 2939668
• Product Code: MBL
• UDI-Device Identifier: 03596010598226
• UDI-Public: 03596010598226
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/05/2021
• Device Model Number: 71335548
• Device Catalogue Number: 71335548
• Device Lot Number: 11BM05444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 08/31/2021
• 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: Required Intervention