MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN CEM HO FEM COMP SZ 11; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71316211
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a thr procedure, an expired implant was opened and cemented in place.By the time it was realized, it was too late to use a new implant.There were no delays in the procedure and no patient injuries reported.There is no medical or surgical intervention planned.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The stem remains implanted.The stem was manufactured in 2009.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Expiration info was verified to be correct.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Potential probable causes that could contribute to the reported event have been identified as user error.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.

• Brand Name: SYN CEM HO FEM COMP SZ 11
• 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: 9517211
• Report Number: 1020279-2019-04590
• Device Sequence Number: 438519
• Product Code: JDI
• UDI-Device Identifier: 03596010410573
• UDI-Public: 03596010410573
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K990369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2019
• Device Model Number: 71316211
• Device Catalogue Number: 71316211
• Device Lot Number: 09KM10260B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 02/15/2020
• Initial Report FDA Received Date: 12/24/2019
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1