MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPEC EF PRI SO 12/14 SZ 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71312102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Osteolysis (2377); Metal Related Pathology (4530)
Date of Event	10/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed on a total hip replacement after 5 years of the primary surgery due to metallosis of some part of the prosthesis.The patient suffered from soft tissue damage and bone loss.It was a changed in the surgical technique.It is unknown if there was a delay in the surgery or the patient health.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms based on the imaging provided, the noted radiolucency in the proximal femoral region and around the acetabulum and the angle of the acetabular cup could represent component migration, and/or micromotion and could not be ruled out as a potential contributing factor to the reported event.The condition of the trunnion was not provided.Additionally, without the requested medical documentation and/or product evaluation, the root cause of the metallic-stained tissue/bone loss could not be fully evaluated and a mal-performance of the components with metallosis could not be confirmed.The patient impact beyond the reported symptoms and revision with a modified surgical procedure could not be determined, as it was reported that the patient status remains unknown.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Some potential probable causes for this event could include damaged product, implant corrosion or wear.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: SPEC EF PRI SO 12/14 SZ 2
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10825973
• Report Number: 1020279-2020-06393
• Device Sequence Number: 16977812
• Product Code: JDI
• UDI-Device Identifier: 03596010195524
• UDI-Public: 03596010195524
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K970351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71312102
• Device Catalogue Number: 71312102
• Device Lot Number: 16DT68518
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 06/12/2021
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71313210 INVIS DST CNT 10MM/71358036 PLY 32ID 55OD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention