MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 28 0 DEG 46-48 SZ D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71333373
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
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 procedure, when the customer reviewed x-rays, it was identified that the liner was worn severely.The surgeon is considering revision, but the date is undecided.It is unknown if this adverse event has been addressed.Patient's current health status is unknown.
Additional Manufacturer Narrative
Given the nature of the alleged incident, the device, could not be returned for evaluation.The provided x-rays were reviewed by the clinical medical team and demonstrated that the head is not centered within the acetabular cup and is consistent with the reported worn liner.However, the clinical/medical investigation concluded that, as of the date of this medical investigation, the supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.With information provided the patient impact cannot be determined, however, it was reported the surgeon is considering a revision.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 based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed in possible adverse effects that wear of the polyethylene articulating surfaces of knee replacement components has been reported following total knee replacement.Higher rates of wear may be initiated by particles of cement, metal, or other debris which can cause abrasion of the articulating surfaces.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 suspect that the product failed to meet any product specifications at the time of manufacture.This event was evaluated by our quality engineering team, and concluded that based on production order review and evaluation of the failure rate and survivorship of the batch, a manufacturing related cause is not evident, and historical review of the reflection liner system does not indicate a systemic wear issue for the device family.A root cause could not be confirmed for this failure mode; however, factors that could contribute to the reported event include joint tightness and implant positioning.The contribution of the device to the reported event could be corroborated as the x-rays confirm the liner is worn and it will be required a revision surgery.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 XLPE 28 0 DEG 46-48 SZ D
• 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: 15214006
• Report Number: 1020279-2022-03656
• Device Sequence Number: 16674976
• Product Code: JDI
• UDI-Device Identifier: 03596010455857
• UDI-Public: 03596010455857
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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: 06/04/2022
• Device Model Number: 71333373
• Device Catalogue Number: 71333373
• Device Lot Number: 12FM03867
• 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: 07/25/2022
• Supplement Date Received by Manufacturer: 11/24/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2012
• 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: Required Intervention; Hospitalization
• Patient Sex: Female