MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM -3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	71343203
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that, when a thr revision was performed on (b)(6) 2023 to remove a competitor's implant (corail stem), a redapt stem size 6 was placed in exchange and the competitor¿s cup was retained.A 32mm oxinium femoral head 12/14 was implanted as well.Some months ago, the patient experienced dislocation, which was addressed by performing a second revision surgery on (b)(6) 2023.During this procedure, the competitor¿s acetabular cup was removed along with the 32mm oxinium femoral head 12/14.The redapt stem remained in situ.A new or3o dual mobility cup was implanted.Patient¿s current health status is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The photograph was reviewed, and revealed that the device shows signs of use.The clinical/medical investigation concluded that, as of the date of this medical investigation the requested clinical/medical documentation has not been provided; however, the mixed manufacturer components cannot be ruled out as a possible contributing factor to the reported dislocation, subsequent oxinium femoral head damage and revision.The impact to the patient was the dislocation, subsequent revision and postoperative convalescence period.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 that dislocation has been identified in warnings and precautions section as a result of improper neck selection, positioning, looseness of acetabular or femoral components, extraneous bone, penetration of the femoral prosthesis through the shat of the femur, fracture of the acetabulum, intrapelvic protrusion of acetabular component, femoral impingement, periarticular calcification, and/or excessive reaming.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 do have reason to suspect that the product failed to meet 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: OXINIUM FEM HD 12/14 32MM -3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 18403229
• Report Number: 1020279-2023-02613
• Device Sequence Number: 14445103
• Product Code: LZO
• UDI-Device Identifier: 03596010474216
• UDI-Public: 03596010474216
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71343203
• Device Lot Number: 19FM15809
• 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: 12/01/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 01/22/2024
• Date Device Manufactured: 06/20/2019
• 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: UNKNOWN 190MM REDAPT STEM SIZE 6
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown