MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71336450
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	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
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device shows damage on the upper area of the polished bowl of the shell, probably from attempted implantation.Quality 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, due to rounding rules defined in 0068391 rev.B, this deviation is considered acceptable to the number of decimal places on the drawing print.Deviations were also noted for the id spherical radius.In the upper area of the polished bowl on either side of the shell, an excessive amount of material has been removed, resulting in a slightly undersized profile in that region.The majority of the id profile is within specification.It is unknown if this dimensional deviation could have impacted product function.No other deviations were noted during inspection.Quality initiated nc-7430 to address this non-conformance.The clinical/medical evaluation concluded that 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.A review of complaint history did not reveal additional complaints for the listed batch.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 have reason to suspect that the product failed to meet product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.A potential probable cause could include but is not limited a manufacturing deficiency.Based on this investigation, the need for corrective action is indicated.Should additional information be received, the complaint will be reopened.This issue is being addressed through our internal quality hold system.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: REF THREE HOLE SHELL 50MM
• 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: 10564133
• Report Number: 1020279-2020-04760
• Device Sequence Number: 11457971
• Product Code: MBL
• UDI-Device Identifier: 03596010454348
• UDI-Public: 03596010454348
• 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): 10/12/2021

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: 71336450
• Device Catalogue Number: 71336450
• Device Lot Number: 19KM10871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 10/10/2021
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 10/12/2021
• 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