MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF CEMENT ACET COM 28/55; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71352855
Medical Device Problem Codes	Degraded (1153); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery was performed on (b)(3) 2010, the patient experienced pain and clicking in hip, and a revision surgery was performed on (b)(3) 2023 due to wear and loosening of the cup, the ref cement acet com 28/55 was exchanged.Patient's current health status is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
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 shell shows signs of use.The head shown in the picture is not a smith and nephew device.The clinical/medical investigation concluded that, patient had a total hip arthroplasty (tha) (b)(6) 2010.It was reported the tha was completed with a reflection acetabular component, stryker femoral head and stryker exeter stem.Patient had a revision 13-years post implantation, due to wear and loosening of the cup.The provided photo does not aid in determining a clinical root cause of the reported events but does show some deformation of the poly liner but cannot conclude if this is wear or related to removal.The endoprosthesis instructions for use notes, mentions ¿do not mix components from other manufacturers.¿ the mix manufacturer of components and the 13-years in vivo cannot be ruled out as possible contributing factors to the reported wear and loosening of the acetabular cup.The patient impact is the revision and expected post-operative 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 in warnings and precautions that the patient should be advised to report any pain and unusual incidences.Position changes in the components may compromise the durability of the implants.Looseness of components has been identified in possible adverse effects section as a result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.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 reason to suspect 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: REF CEMENT ACET COM 28/55
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 18274817
• Report Number: 1020279-2023-02402
• Device Sequence Number: 3227495
• Product Code: LPH
• UDI-Device Identifier: 03596010198259
• UDI-Public: 3596010198259
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K932755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2024

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 Expiration Date: 01/31/2019
• Device Catalogue Number: 71352855
• Device Lot Number: 09AT27980
• 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: 11/16/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 01/15/2024
• Date Device Manufactured: 01/30/2009
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Sex: Unknown