MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF LNR 28X50-52 20 DEG SZ E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71742850
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to eccentric femoral head/polyethylene positioning on x-ray and radiographic appearance of osteolysis in proximal femoral region.Head and liner removed and replaced with new prosthesis.
Additional Manufacturer Narrative
The associated reflection acetabular liner and cobalt chrome femoral head were not made available for evaluation.Therefore a product analysis could not be performed.However, device details were provided.Thus, the review of manufacturing records was conducted which did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.There is no information that would suggest the implanted devices failed to meet specifications.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A clinical evaluation noted that without the supporting medical/surgical records, lab/pathology results, and/or the analysis of the explanted components, the root cause of the reported issues cannot be confirmed but the provided images could indicate a steep angle of implantation of the shell which could have an impact to the reported wear but this can¿t be concluded based on the information provided.The patient impact beyond the revision and expected post-op healing pain cannot be determined.No further clinical assessment is warranted at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: REF LNR 28X50-52 20 DEG SZ E
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8560974
• Report Number: 1020279-2019-01703
• Device Sequence Number: 19380987
• Product Code: LPH
• UDI-Device Identifier: 03596010232267
• UDI-Public: 03596010232267
• Combination Product (Y/N): N
• PMA/510(K) Number: K932755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2019

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 Expiration Date: 04/21/2012
• Device Catalogue Number: 71742850
• Device Lot Number: 02DM01437
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 08/09/2019
• 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