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

Catalog Number	71302604
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to dislocation on (b)(6) 2018.
Additional Manufacturer Narrative
The affected cobalt chrome femoral head and tandem bipolar shell/liner were returned and evaluated.A lab analysis conducted during this investigation indicated that the bipolar liner construct was returned assembled with internal polyethylene components fully locked in place.No visual damage was observed.Visual examination of the femoral head did not reveal any signs of damage, but the head appears too large to pass through the opening of the liner construct when stacked.The head would need to pass through the opening in order to disassemble.This demonstrates that the head diameter was large enough to be constrained within the bi-polar component, as designed.No damage or deformation was visible on the locking ring.Thus, no root cause of this issue can be determined.This issue has been elevated to our risk assessment process.Our investigation indicated that upon further investigation it was concluded that the complaint device appears to have been damaged during surgery or extraction, as all parts checked with calipers/micrometer passed the shop floor gages.Therefore the complaint cannot be confirmed.Our investigation including a review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A clinical evaluation noted that no clinical relevant documents were provided to conduct a thorough medical assessment.No medical assessment is warranted at this time.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• 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: 7767887
• Report Number: 1020279-2018-01497
• Device Sequence Number: 2365657
• 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 Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

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: 71302604
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 03/05/2019
• 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