MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HD 32 + 4; PRSTHSS, HP, SM-CNSTRND, MTL/PLYMR, PRS UNCMNTD

Model Number	71303204
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported revision surgery was performed due to a suspected trunionosis.
Additional Manufacturer Narrative
It was reported revision surgery was performed due to a suspected trunionosis.The affected cobalt chrome femoral head, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.Possible causes could include but are not limited to patient medical history or patient reaction.Based on this investigation, the need for corrective action is not indicated.It appears this complaint is a duplicate of a previous complaint ((b)(4), report number 1020279-2020-00150).No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: COCR 12/14 FEM HD 32 + 4
• Common Device Name: PRSTHSS, HP, SM-CNSTRND, MTL/PLYMR, PRS UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9532350
• Report Number: 1020279-2019-04680
• Device Sequence Number: 11377811
• Product Code: LPH
• UDI-Device Identifier: 03596010194190
• UDI-Public: 03596010194190
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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: 71303204
• Device Catalogue Number: 71303204
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 04/14/2020
• 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