MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71336452
Medical Device Problem Codes	Difficult to Insert (1316); Defective Device (2588)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteopenia/ Osteoporosis (2651); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a right thr procedure, after implanting the out cup 71336450 (ref three hole shell 50mm), liner 71742850 (ref lnr 28x50-52 20 deg sz e) couldn't be implanted.Try to use the liner 71333324 (ref xlpe 28 20 deg 50-52 e), still didn't work.Try to use the out cup of 71336452 (ref three hole shell 52mm), still did not work.Due to osteoporosis of the patient, the outer cup was loose and could not be tightened many times, resulting in partial loss of the posterior wall bone.Finally, the reinforce ring and bone cement cup were used to complete the surgery.In addition, there were the bone graft and hercules bone cement to prevent infection.A delay greater than 30 min was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
It was reported that during a right thr procedure, the surgeon had trouble getting the cup and liner to tighten, trying with two different liners and shells.Due to osteoporosis of the patient, the outer cup was loose and could not be tightened many times, resulting in partial loss of the posterior wall bone.Finally, a reinforce ring and bone cement cup were used to complete the surgery.The affected 3-hole shell, intended for use in treatment, was returned and evaluated.A visual inspection of the device shows no obvious signs of damage.Our quality team completed dimensional analysis on the returned product for all critical-to-quality features that could potentially affect liner seating.A minor deviation was noted for spline form on cmm; however, this deviation is considered acceptable to the number of decimal places on the drawing print.No other deviations were noted.The failure mode cannot be confirmed via dimensional analysis of the returned product.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.Based on this investigation, the need for corrective action is not indicated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.A medical analysis noted x-rays and an abbreviated surgery record were provided for review.The medical information provided about the patient was limited to her rheumatoid arthritis, severe osteoporosis, fracture of the femoral neck and several rib fractures.There was no mention of a traumatic accident or any precipitating event to cause these fractures.The impact to the patient would be the pain of the fractures, the surgery and the recovery.Based on the available information, the issues with the shells and liners was likely as the report stated, due to her severe osteoporosis.Her poor bone quality required bone grafting and cement to reinforce the bone and stabilize the components.Failure of the implants cannot be concluded.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 52MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10564112
• Report Number: 1020279-2020-04759
• Device Sequence Number: 2779396
• Product Code: MBL
• UDI-Device Identifier: 03596010454355
• UDI-Public: 03596010454355
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71336452
• Device Catalogue Number: 71336452
• Device Lot Number: 19KM10894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2020
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 02/27/2021
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 03/02/2021
• 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: Required Intervention
• Patient Age: 40 YR