MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMP 15 STEM PRIMARY HO; PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE

Catalog Number	71291502
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	10/25/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a revision surgery performed due to debilitating right hip pain and instability.Also, metallosis and reactive inflammatory fluid surrounding the hip joint were discovered.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The medical investigation concluded that the clinical information provided, stating ¿copious amount of reactive fluid within the joint¿ may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.The root cause for the ¿mechanical loosening¿ resulting in the second revision cannot be concluded without supporting documentation.No further investigation is warranted at the time.Without the actual product involved our investigation cannot proceed.If the device or new information is received in the future, these complaints can be re-opened.

• Brand Name: EMP 15 STEM PRIMARY HO
• Common Device Name: PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8400504
• Report Number: 1020279-2019-00979
• Device Sequence Number: 2326480
• Product Code: MEH
• UDI-Device Identifier: 03596010561534
• UDI-Public: 03596010561534
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2019

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: 04/26/2021
• Device Catalogue Number: 71291502
• Device Lot Number: 11DM16786
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 09/22/2019
• 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
• Patient Age: 71 YR