MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STANDARD OFFSET NEUTRAL MODULAR NECK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71352111
Medical Device Problem Code	Pitted (1460)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed to remove modular neck because patient was having a reaction to corrosion on this implant.
Additional Manufacturer Narrative
The associated standard offset modular neck was not returned for evaluation.A clinical evaluation noted that no clinical documents were provided for review to confirm the reaction to corrosion.Therefore, no further clinical medical assessment is warranted at this time.Our investigation indicated that the associated device in this complaint is included in a field action launched in 2016.No additional actions are being taken at this time.Should the device or additional information be received, the complaint will be reopened.
Additional Manufacturer Narrative
The devices, intended for use in treatment, were not returned for evaluation and the reported event could not be confirmed.The devices were manufactured in 2009, 2010, 2011 and 2012.A review of the device history records for the listed batches did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.The medical investigation concluded that the intraoperative findings of black fluid, the reported metallosis reaction and slightly elevated cobalt levels may be consistent with findings associated with metal debris, however the root cause cannot be confirmed, and it cannot be concluded that the reported reactions/events were associated with a mal-performance of the implant.The root cause of the pt¿s post-operative dislocation and pain, which led to the lt tha revision, cannot be determined, as complete medical records for the period between the primary tha and the revision have not been provided, and details regarding the patient¿s post-operative medical history, activity level and other clinically relevant information have not been provided.The patient impact beyond the revision, and post-operative healing/pain cannot be determined.Some potential probable causes could include patient reaction or a post-operative healing issue.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: STANDARD OFFSET NEUTRAL MODULAR NECK
• 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: 8210607
• Report Number: 1020279-2019-00021
• Device Sequence Number: 10832152
• Product Code: LPH
• UDI-Device Identifier: 03596010619532
• UDI-Public: 03596010619532
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K072417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2020

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: 71352111
• Device Catalogue Number: 71352111
• Device Lot Number: 09LTM0004B
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 12/10/2018; 08/04/2020
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 06/06/2019; 08/09/2020
• 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
• Patient Age: 63 YR