MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF LNR 26ID 0 DEG SZ D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71740646
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	08/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a thr surgery had been performed on an unknown date, the patient experienced severe metallosis and pseudo tumor of the right hip.It is unknown how this was solved/ treated.Current health status of patient is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the metallosis was confirmed.The clinical/medical investigation concluded that, smith and nephew has not received any relevant clinical supporting documents to perform a thorough medical investigation.In addition, it was reported the hospital unknowingly disposed of the devices.Therefore, without the requested clinical information or the device, the root cause of the reported failure cannot be determined.Only the procedural chart sticks were provided and reviewed.Per subsequent e-mail, the surgeon reported the patient dislocated and was in a lot of pain.Based on the reported symptoms it cannot be concluded that the events/clinical reactions of pain, severe metallosis and pseudo tumor of the right hip were associated with a mal performance of the implant.According to the complaint, this issue was resolved by removing the implants and clearing up the infected tissue.Since it was reported the patient is currently recovering well.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this complaint would be re-assessed.A review of complaint history did not reveal additional complaints for the listed device for the same failure mode.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.Some potential probable causes for this event could include damaged product, implant corrosion or wear.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 LNR 26ID 0 DEG SZ D
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12336601
• Report Number: 1020279-2021-06435
• Device Sequence Number: 11933818
• Product Code: LPH
• UDI-Device Identifier: 03596010231840
• UDI-Public: 3596010231840
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2021

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 Catalogue Number: 71740646
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 10/09/2021
• 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: Other