MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71337650
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a tha surgery, an r3 20 deg xlpe acet lnr 32mm x 50mm and an r3 3 hole acet shell 50mm were planned to be used, but it was found that the outer cup and inner liner did not get locked.There was not obvious change in the mechanism.The 50 mm shell and liner were removed.The procedure was resumed, after a significant delay, with a s+n back-up device.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the associated devices were returned and evaluated a visual inspection of the returned liner reveals some scratches on the surface of the device.The shell was returned as well and reveals a few scratches.The devices show signs of normal wear.However, the videos provided revealed that the liner could not be inserted.A dimensional evaluation reveals the surfaces of the implant are visually damaged due to the attempted implantation.Plastic is easily distorted during implantation activities.These surface finish defects (dings, scratches, scuffs, rubs) are enough to alter the measured reading during evaluation.For this reason, the cause of the complaint cannot be confirmed as the result of a non-conforming part.Based on a historical search, this complaint is the only reported ¿ there does not appear to be a systemic failure across multiple parts of this manufacturing batch at this time.No further escalation activities will be pursued at this time.If additional complaints for this batch are filed, this record will be reviewed for relevance and consideration.Based on the information provided, the unsatisfactory experience could be confirmed.A review of complaint history revealed similar events for the acetabular shell over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of complaint history revealed similar events for the acetabular liner over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of complaint history revealed similar events for the acetabular liner over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.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 revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Factors that could contribute to the reported event include size selected or insertion technique.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.We consider this investigation closed.

• Brand Name: R3 20 DEG XLPE ACET LNR 32MM X 50MM
• 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: 17455562
• Report Number: 1020279-2023-01541
• Device Sequence Number: 2546015
• Product Code: JDI
• UDI-Device Identifier: 03596010598486
• UDI-Public: 03596010598486
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2023

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 Catalogue Number: 71337650
• Device Lot Number: 22EM22175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: R3 3 HOLE ACET SHELL 50MM, LOT#:22DM11413.
• Patient Sex: Unknown