MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM +8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	71343208
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	05/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after thr surgery, there were high levels of metals found in the blood of the patient.A revision surgery was performed on (b)(6) 2021 to treat this event.The sl-plus stem lateral 2 non-cemented (case-(b)(4)) and the oxinium fem hd 12/14 32mm +8 (case-(b)(4)) were explanted.Patient outcome is unknown.
Additional Manufacturer Narrative
The device, intended for use in treatment, was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical / medical investigation concluded that, with the information provided the clinical root cause of the reported ¿high levels of metals in the blood¿ and metallotic synovitis cannot be confirmed, and it cannot be concluded that the reported events/clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.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 the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to material in use or patient reaction.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.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.The device does not show signs of any form of degradation or severe damage.The clinical/medical evaluation concluded that with the information provided the clinical root cause of the reported ¿high levels of metals in the blood¿ and metallotic synovitis cannot be confirmed, and it cannot be concluded that the reported events/clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.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.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 and instructions for use documents revealed this failure mode and potential harm was previously identified.Some potential probable causes for this event could include damaged product, material in use.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: OXINIUM FEM HD 12/14 32MM +8
• 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
• MDR Report Key: 11902609
• Report Number: 1020279-2021-04773
• Device Sequence Number: 19718456
• Product Code: LZO
• UDI-Device Identifier: 03596010474230
• UDI-Public: 03596010474230
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2021
• Device Model Number: 71343208
• Device Catalogue Number: 71343208
• Device Lot Number: 11AM17145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 07/30/2021; 09/02/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 07/30/2021; 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention