MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 28MM X MM50; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71334950
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that after a thr surgery performed on (b)(6) 2024, the patient experienced dislocation on (b)(6) 2024.The patient was booked for an open reduction procedure, during which it was noticed that the head was not properly reducing into the liner.Upon reviewing the records, it was discovered that there was a mismatch between the head and the liner due to the placement of the wrong size of liner in the primary surgery.During the primary surgery, the wrong liner was opened, and even though the correct liner was requested, both liners were opened on the table, and the wrong liner was handed.Due to the unavailability of the correct liner size during the open reduction procedure, there was a four-hour delay while awaiting the appropriate liner size.Following this delay, the incorrect liner, a r3 20 deg xlpe acet lnr 28mm x mm50, was exchanged for the correct size, a r3 20 deg xlpe acet lnr 32mm x 50mm.The patient is currently in the process of recovering.
Additional Manufacturer Narrative
H3, h6: although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the liner.The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that based on information provided, human error due to the inadvertent mismatch between the head and the liner and the placement of the incorrect size of liner in the primary surgery likely caused the dislocation and subsequent revision and the 4-hours surgical delay.According to the information provided, it is highly likely the instructions for use was not adhered to in the primary procedure.There were no clinical factors that would have caused or contributed to the reported adverse events.Therefore, it cannot be concluded that the reported adverse events were related to a mal-performance of the implant or implant failure.Since, there was no harm alleged to this patient due to the 4-hour intra-operative surgical delay and the patient is still recovering, no further clinical/medical assessment can be rendered at this time.The impact to the patient beyond the mismatch between the head and liner, the subsequent revision, the 4-hour surgical delay and expected transient post-op convalescence period cannot be determined since the patient is still recovering.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 instructions for use documents for total hip systems revealed in warnings and precautions that the surgeon should be thoroughly familiar with the implants, instruments, and surgical procedure prior to performing the surgery, also improper selection, placement, positioning, and fixation of the implant components may result in unusual stress conditions and subsequent early failure of the components.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.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.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.

• Brand Name: R3 20 DEG XLPE ACET LNR 28MM X MM50
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 19280010
• Report Number: 1020279-2024-00910
• Device Sequence Number: 15370904
• Product Code: JDI
• UDI-Device Identifier: 03596010598110
• UDI-Public: 03596010598110
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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 Catalogue Number: 71334950
• Device Lot Number: 21GM16181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 71335550/23MW08213/R3 3 HOLE ACET SHELL 50MM.; 71343203/23GM05093/OXINIUM FEM HD 12/14 32MM -3.; 75100465/D2401557/POLARSTEM STEM STD TI/HA 2 NON-C.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female