MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 58MM; PROSTHESIS,HIP,SEMI-CONSTRAINED,UNCEMENTED,METAL/POLY,POROUS

Model Number	71331858
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that it was noticed when opening the box with r3 shell the hcp discovered a hair strand on the inside of the cover on the inner-box with the implant.The delivery process to sterile field was stopped and another box with same implant was opened and implanted in the patient.No injury to the patient.No delay.
Additional Manufacturer Narrative
D8 and d9: device returned.G3, h2,h3 and h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device has a hair stuck to the inside of the outer sterile tray lid.This event was investigated through the nonconformance process and was found to be an isolated event.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.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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: R3 0 HOLE ACET SHELL 58MM
• Common Device Name: PROSTHESIS,HIP,SEMI-CONSTRAINED,UNCEMENTED,METAL/POLY,POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10987256
• Report Number: 1020279-2020-07348
• Device Sequence Number: 4330136
• Product Code: MBL
• UDI-Device Identifier: 03596010597625
• UDI-Public: 03596010597625
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71331858
• Device Catalogue Number: 71331858
• Device Lot Number: 19KW16522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1