MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CPCS COCR PRIM SO 12/14 SZ 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71312363
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during procedure, while the surgeon was reducing the hemi hip with all implants in place, the 22 head disassociated from the tandem implant and stayed on the cpcs cocr prim so 12/14 sz 3.The surgeon was able to remove the head from stem.A second try was attempted but implant kept disassociating even though the ring in tandem was secure.On the second time of trying to remove the head from the stem the whole cemented stem came out.Surgeon had to place new stem and whole new tandem implants.There was a delay greater than 30 min due to this malfunction.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this case reports that while reducing the hemi hip with all implants in place, the head disassociated with the stem, and was removed.The head disassociated from the stem a second time, and upon attempting to remove it, the entire cemented stem came out.The procedure was completed using a new stem.Without responses to the documentation/information requests, the reported event could not be further assessed.Per complaint details, there was no patient injury reported, and the was a surgical delay greater than 30 minutes.No further clinical assessment can be rendered at this time.Should additional clinically relevant documentation become available, the clinical/medical task may be re-opened.A review of complaint history on the listed part revealed no prior complaints for the listed batch 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.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Possible causes could include but not limited to traumatic injury, surgical technique or size of device.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.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.We consider this investigation closed.

• Brand Name: CPCS COCR PRIM SO 12/14 SZ 3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11327133
• Report Number: 1020279-2021-01344
• Device Sequence Number: 10977516
• Product Code: JDI
• UDI-Device Identifier: 03596010462022
• UDI-Public: 03596010462022
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K823727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2021

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: 71312363
• Device Catalogue Number: 71312363
• Device Lot Number: 20JM15932
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 03/21/2021
• 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