MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HD 26 + 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71302604
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation.Head and liner exchanged.
Additional Manufacturer Narrative
The associated devices, used in treatment, were returned and evaluated.A visual inspection of the returned devices could not confirm the stated failure mode.The head had scratches and dings on the taper region and outside, most likely from extraction.There was deformation on the lateral face of the lock ring on the bipolar, which is consistent with stem/ neck impingement.The bipolar construct was returned assembled with the components locked in place.No significant damage or deformation was visible on the bipolar.No conclusions as to the cause of this issue can be determined.The medical investigation concluded that the x-ray provided confirms the report.Based on the limited information provided, the root cause of the reported dislocation cannot be determined.However, post implantation care cannot rule out as a contributing factor.The impact to the patient beyond the revision cannot be concluded.Should additional information becomes available this issue can be re-elevated.A dimensional inspection was attempted but the device was too damaged to obtain accurate measurements.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes of this event could include a traumatic event or improper sizing.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: COCR 12/14 FEM HD 26 + 4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8942216
• Report Number: 1020279-2019-03218
• Device Sequence Number: 19485272
• Product Code: LPH
• UDI-Device Identifier: 03596010194084
• UDI-Public: 03596010194084
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

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: 71302604
• Device Catalogue Number: 71302604
• Device Lot Number: 18KM20135
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 02/26/2020
• 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