MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG +4 XLPE ACET LNR 32MM X 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71337950
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	03/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after thr surgery had been performed on (b)(6) 2014, the patient experienced a bad fall and posterior continues dislocations.This adverse event was address through a revision surgery, (b)(6) 2023, in which the surgeon was aware that the r3 20 deg +4 xlpe acet lnr 32mm x 50mm was broken, therefore the r3 0 hole acet shell 50mm and the r3 20 deg +4 xlpe acet lnr 32mm x 50mm were explanted and changed for a r3 multi-hole cup and a constrained liner.Patient status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: case(b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, during surgery, the surgeon found that part of the posterior lip of the liner broke off.The piece could be removed but was lost in the discarding tissue debris.A r3 multi-hole cup was inserted with constrained liner.The surgeon does not need an investigation as he does not fault the implant.The undated x-rays were reviewed and appears to confirm the reported dislocation and appears in the left hip.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.Although, the reported continuous dislocations and subsequent revision is consistent with the reported intraoperative findings of the ¿part of the posterior lip of the liner being broken off.¿ with the limited information provided the clinical root cause of the broken liner cannot be confirmed.The patient impact beyond the revision and postop convalescence period cannot be determined with the information provided.No further clinical assessment is warranted at this time.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 adverse events in primary and revision surgery that failure to observe the warnings and precautions, trauma, strenuous activity, implant alignment, patient non-compliance, involuntary muscular disorders, improper or duration of service increase the risk of loosening, bending, cracking, or fracture of implant components, which may lead to revision surgery.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.According to the material specification, quality and manufacture of materials should be controlled.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected, surgical technique, postoperative care, patient anatomy, abnormal loading of limb, excessive forces and/or traumatic injury.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.
Additional Manufacturer Narrative
The reported event was analyzed.Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the liner.Therefore, no investigation is deemed for the other devices.The associated device was returned and evaluated.A visual inspection of the returned liner reveals discoloration, signs of wear and a large piece of the implant missing.The visual inspection of the returned femoral head reveals multiple scratches in the surface of the device.The visual inspection of the returned cup reveals a foreign substances on the entire implant.The clinical/medical investigation concluded that, although, the reported continuous dislocations and subsequent revision is consistent with the reported intraoperative findings of the ¿part of the posterior lip of the liner being broken off.¿ with the limited information provided the clinical root cause of the broken liner cannot be confirmed.The patient impact beyond the revision and postop convalescence period cannot be determined with the information provided.No further clinical assessment is warranted at this time.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 adverse events in primary and revision surgery that failure to observe the warnings and precautions, trauma, strenuous activity, implant alignment, patient non-compliance, involuntary muscular disorders, improper or duration of service increase the risk of loosening, bending, cracking, or fracture of implant components, which may lead to revision surgery.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.According to the material specification, the quality and manufacture of ultra-high-molecular-weight polyethylene, rod compression-molded and plate shall be controlled.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal loading of limb, excessive forces and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should 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 +4 XLPE ACET LNR 32MM X 50MM
• 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: 16632824
• Report Number: 1020279-2023-00686
• Device Sequence Number: 7170461
• Product Code: JDI
• UDI-Device Identifier: 03596010598646
• UDI-Public: 03596010598646
• 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: 2014
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2023

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: 71337950
• Device Catalogue Number: 71337950
• Device Lot Number: 18LM18909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 04/19/2023; 08/25/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 04/20/2023; 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2018
• 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: OXINIUM FEM HD 12/14 32MM +4, LOT#:18EM16066.; R3 0 HOLE ACET SHELL 50MM, LOT#:13KM03251.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 78 KG