MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71336452
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after total hip replacement was performed on (b)(6) 2009, the patient experienced pronounced osteolysis in the area of the right acetabulum, pain and cracking noises in the right leg.This adverse event was treated with a revision surgery on (b)(6) 2022, in which fracture and complete wear and tear of the polyethylene inlay was observed.In addition, metallosis was observed on the socket; a sample was collected and test results remain pending.Patient is currently in severe pain and still unable to walk without crutches four months post-operative.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, it should be noted the acetabular osteophytes pre implant and pre-revision cannot be ruled out as contributing factors to the reported clinical reactions/ events.The reported pain, complete wear of the polyethylene inlay, and loosening of the acetabulum may be consistent with the reported metallosis but the root cause cannot be confirmed as it could also be seen as a result of the very large osteolysis, that could also lead to the reported loosening of the acetabulum and complete wear of the polyethylene inlay.The patient reports continued severe pain and the use of crutches for ambulation 4-months post-revision.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, patient medical history, adverse reaction, bone quality, irregular implant interaction and/or abnormal motion over time.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
Additional information: d1, d2a, d2b, d4, h4, d9, h3.
Additional Manufacturer Narrative
Corrected data: h6 (health effect - clinical code, type of investigation, investigation findings).Updated results of investigation: the associated device was returned and evaluated.A visual inspection of the returned device reveals bone attached to the shell.The device shows signs of severe wear.A lab analysis reveals the examination of the shell found a swirling wear pattern possibly caused by contact with the femoral head.In addition, a small fragment of poly liner was observed to be embedded in the center hole of the shell, possibly from extraction.Macroscopic/microscopic examination of the femoral head showed black discoloration and wear scratches on the top of the head, possibly related to contact with the metal shell, as well as scratches on the sides that may have been caused by extraction.No definitive conclusions as to the cause of these issues can be determined.The clinical/medical evaluation concluded that it should be noted the acetabular osteophytes pre implant and pre-revision cannot be ruled out as contributing factors to the reported clinical reactions/ events.The reported pain, complete wear of the polyethylene inlay, and loosening of the acetabulum may be consistent with the reported metallosis but the root cause cannot be confirmed as it could also be seen as a result of the very large osteolysis, that could also lead to the reported loosening of the acetabulum and complete wear of the polyethylene inlay.The patient reports continued severe pain and the use of crutches for ambulation 4-months post-revision.A review of complaint history for the part number over the past 24 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 manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A review of instructions for use for total hip systems revealed in adverse events in primary and revision surgery that with all joint replacements, asymptomatic, localized, progressive bone resorption (osteolysis) may occur around the prosthetic components as a consequence of foreign body reaction to particulate wear debris.Osteolysis can lead to future complications necessitating the removal or replacement of prosthetic components.Besides, revealed that, although rare, metal sensitivity reactions and/or allergic reactions to foreign materials have been reported in patients following joint replacement, which have required device removal.Also, revealed that wear of the polyethylene, metal and ceramic articulating surfaces of acetabular components may occur as an adverse event.Higher rates of wear may be initiated by the presence of particles of cement, metal, or other debris which can develop during or as a result of the surgical procedure and cause abrasion of the articulating surfaces.Lastly, 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.Factors that could contribute to the reported event include irregular implant interaction, wear, abnormal motion over time or patient condition.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 future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: REF THREE HOLE SHELL 52MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, 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: 15748769
• Report Number: 1020279-2022-04719
• Device Sequence Number: 16889939
• Product Code: MBL
• UDI-Device Identifier: 03596010454355
• UDI-Public: 03596010454355
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K960094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/22/2023
• 2 Devices were Involved in the Event: 1 2

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: 10/29/2018
• Device Model Number: 71336452
• Device Catalogue Number: 71336452
• Device Lot Number: 08KM11555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 11/29/2022; 03/28/2023; 06/21/2023
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 12/08/2022; 04/03/2023; 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2008
• 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: UNKN. SL-PLUS STEM.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 60 KG