MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CONT RECON RING 50/46 RT; MESH, SURGICAL, ACETABULAR, HIP, PROSTHESIS

Model Number	71337250
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a thr surgery, a cont recon ring 50/46 rt could not be inserted into the acetabular.Surgery was completed with a sn back-up device, after a 1-hour surgical delay.No harm to the patient or further complications reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Section h3, h6: the device was not returned for evaluation.The pictures provided were reviewed and could not confirm that the device could not be inserted into the acetabular.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.According to the inspection procedure, the final inspection includes verifying parts are free of cracks, forging laps, sharp edges or burrs, part configuration and surface finish per print should also be verified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include size selected or poor insertion technique.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The visual inspection did not reveal the stated failure mode.A dimensional evaluation performed on the device revealed that there was no found evidence that the product was out of tolerance in the areas that would cause the compliant allegations.No need for any further actions.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.According to the inspection procedure, the final inspection includes verifying parts are free of cracks, forging laps, sharp edges or burrs, part configuration and surface finish per print should also be verified.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: CONT RECON RING 50/46 RT
• Common Device Name: MESH, SURGICAL, ACETABULAR, HIP, PROSTHESIS
• 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: 15090367
• Report Number: 1020279-2022-03449
• Device Sequence Number: 5101791
• Product Code: JDJ
• UDI-Device Identifier: 03596010293336
• UDI-Public: 03596010293336
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K962541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2023

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 Expiration Date: 07/26/2026
• Device Model Number: 71337250
• Device Catalogue Number: 71337250
• Device Lot Number: 16DM10026A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 10/20/2022; 05/16/2023
• Initial Report FDA Received Date: 07/23/2022
• Supplement Report FDA Received Date: 10/21/2022; 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2016
• 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
• Patient Sex: Unknown