MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 28 20 DEG 50-52 E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71333324
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 liners to tighten with two different liners and shells.Finally, a 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.The affected reflection liner, used in treatment, was returned and evaluated.A visual inspection of the returned device shows damage on the outer surface of the part probably from the attempted insertion.Dimensional analysis could not be performed as the damage/deformation on the part would not allow for accurate measurement.Our investigation including a review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.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.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 that a delay greater than 30 min was reported.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 were likely due to her severe osteoporosis as reported.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 XLPE 28 20 DEG 50-52 E
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10564089
• Report Number: 1020279-2020-04758
• Device Sequence Number: 11457970
• Product Code: JDI
• UDI-Device Identifier: 03596010455611
• UDI-Public: 03596010455611
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002747
• 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): 12/15/2020

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: 71333324
• Device Catalogue Number: 71333324
• Device Lot Number: 18KM26491
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 12/15/2020
• 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