MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71337652
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during hip replacement, it was observed that an r3 acetabular liner 32mm inner diameter x outer diameter 52mm had number 50 inscribed on the external box of the implant, instead of number 52.The surgery was resumed, without any delay, the same device.When reviewing the implants used, it was noticed that the implant with the reference 32/52 sticker is missing, and it was later notified by x-ray that there was an anomaly with the insert.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Section b5 and d3 were updated according to the new information received.Section h6 was corrected according to the new information received.Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the product was not faulty and the cause was associated with an omission on the part of the surgical instrumentation operator that confused the measurements of the implant.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
Event or Problem Description
It was reported that, during hip replacement, it was thought that an r3 acetabular liner 32mm inner diameter x outer diameter 52mm had number 50 inscribed on the external box of the implant, instead of number 52.The surgery was resumed, without any delay, the same device.When reviewing the implants used, it was noticed that the cause was associated with an omission on the part of the surgical instrumentation operator that confused the measurements of the implant.Patient's health is stable and was not injured as consequence of this problem.

• Brand Name: R3 20 DEG XLPE ACET LNR 32MM X 52MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12908661
• Report Number: 1020279-2021-08452
• Device Sequence Number: 3807874
• Product Code: JDI
• UDI-Device Identifier: 03596010598493
• UDI-Public: 03596010598493
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2022

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: 71337652
• Device Catalogue Number: 71337652
• Device Lot Number: 21GM09735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Female