MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 58MM; PRSTHSS,HIP,SMI-CNSTRND,UNCMNTD,MTAL/PLYMR,PRS

Model Number	71336458
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during tha surgery, the liner can't be placed smoothly after the surgeon implanted the reflection acetabular system.The procedure was completed with a smith and nephew back up device.There was a delay greater than 30 minutes.No harm or injury reported on patient.
Additional Manufacturer Narrative
It was reported that during tha surgery three sets of the reflection acetabular system were replaced due to the liner not being placed smoothly.The tha was completed with other sn backup devices without patient harm or injury reported.The affected reflection three hole shell, used in treatment, was returned and evaluated.A visual inspection of the returned device shows minor damage on the part, probably from the attempted implantation.A dimensional analysis was performed by quality group to check all critical-to-quality features related to liner mating.No deviations were detected during this analysis.The reported failure mode could not be confirmed via dimensional evaluation of the returned part.Our investigation including a review of the manufacturing records for the listed batch did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of the complaint history revealed no other complaint for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.The requested medical documentation was not provided for inclusion in the medical investigation.No further medical assessment can be rendered at this time.Some potential causes of the reported event could include but are not limited to surgical technique used, size of device or user/procedural variance.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: REF THREE HOLE SHELL 58MM
• Common Device Name: PRSTHSS,HIP,SMI-CNSTRND,UNCMNTD,MTAL/PLYMR,PRS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10729960
• Report Number: 1020279-2020-05710
• Device Sequence Number: 4123151
• Product Code: MBL
• UDI-Device Identifier: 03596010454386
• UDI-Public: 03596010454386
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K960094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71336458
• Device Catalogue Number: 71336458
• Device Lot Number: 19DM03836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 05/10/2021
• 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: Hospitalization; Required Intervention