MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CPCS COCR PRIM HO 12/14 SZ 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71312372
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed to the patient due to an infection.Three devices explanted.No additional information available.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed to the patient due to an infection.The associated acetabular cup, tandem unipolar and cobalt chrome high offset stem were not returned for evaluation.Therefore, no product analysis could be performed.After repeated requests, smith and nephew has been unable to obtain device details.As device details were not made available, a device history record and sterilization documentation review cannot be completed.Also, a complaint history review could not be performed with any accuracy due to lack of batch information.A clinical evaluation noted that no relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.Without the return of the actual products involved and no lab results, our investigation of this report is inconclusive.It should be noted that a bhr cup being used with a tandem unipolar head is considered off label per our product development engineer.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, this complaint will be reopened and reevaluated.

• Brand Name: CPCS COCR PRIM HO 12/14 SZ 2
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8601009
• Report Number: 1020279-2019-01875
• Device Sequence Number: 2193469
• Product Code: JDI
• UDI-Device Identifier: 03596010462152
• UDI-Public: 03596010462152
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K823727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019

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 Catalogue Number: 71312372
• Initial Date Received by Manufacturer: 04/19/2019
• Supplement Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 11/12/2019
• 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