MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 30MM; PRSTHSIS, HIP,SMI-CNSTRAIND,UNCMNTD,METAL/POLYMER,NON-POROUS,CALICUM-PHOSPHATE

Catalog Number	71332530
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	02/13/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent an aspiration on the left hip due to an infection.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and although an aspiration was performed to rule out an infection prior to the left hip revision, it was unsuccessful and ¿prematurely terminated¿ per patient request.The pathology results of the left hip revision intra-op specimens revealed ¿fibroligamentous tissues¿ which are consistent with an alval/pseudotumor.The patient impact beyond the reported discomfort and anxiety during the attempted aspiration cannot be determined.No further medical assessment can be rendered at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: REF SPHER HEAD SCREW 30MM
• Common Device Name: PRSTHSIS, HIP,SMI-CNSTRAIND,UNCMNTD,METAL/POLYMER,NON-POROUS,CALICUM-PHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8139865
• Report Number: 1020279-2018-02709
• Device Sequence Number: 215530
• Product Code: MEH
• UDI-Device Identifier: 03596010460479
• UDI-Public: 03596010460479
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K990666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2019

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: 03/19/2022
• Device Catalogue Number: 71332530
• Device Lot Number: 12CM13172
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 04/09/2019
• 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: Other; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 180