MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HD 32 - 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71303203
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery when the insert implant was opened in or the plastic material from the wrapping was stuck on the cocr head.There was no new head of the same size available, the surgeon was forced to take a larger size.More than 30 minutes delay was reported.
Additional Manufacturer Narrative
The associated cocr head was returned for evaluation.The reported deficiency of polyethylene pouch material being adhered to the articulating surface of the femoral head was confirmed.Manufacturing review determined that the packaging design at the time this batch was manufactured used low-density polyethylene pouches.Since the manufacture of this head the pouch material has been upgraded to a high-density polyethylene pouch.Although unconfirmed if this event is attributable to heat exposure an extensive root cause investigation was conducted; however, the failure mode could not be reproduced during several tests of processes based on heating the product and packaging materials beyond specification.This failing is very visible and can be easily detected allowing the user the opportunity to exchange the implant or possibly remove the material from the device and completing the procedure as intended.Cytotoxicity testing performed on the low-density polyethylene pouch determined that no leachable substances would be released in cytotoxic concentrations.Furthermore, the implant ifu instructs the user to inspect both the device and packaging for damage and to not use it if damage is visible.Complaint history review found that since the upgrade to the packaging materials the noted failure mode has not recurred.The review also found that of the 100 units released for this batch number this is the only return for any reason.No cocr heads with this batch number exist in any inventory.A relationship between the device and the reported incident was not confirmed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device had some residue on the articular surface.The device was manufactured in 2012.This failure mode has been previously identified.Since the manufacturing of the complaint device, changes have been implemented to reduce the occurrence of this failure.This device was manufactured prior to the implementation of those changes.This failure was previous address by our internal quality hold process.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: COCR 12/14 FEM HD 32 - 3
• 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: 8561059
• Report Number: 1020279-2019-01707
• Device Sequence Number: 13869808
• Product Code: LPH
• UDI-Device Identifier: 03596010194183
• UDI-Public: 03596010194183
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2019

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: 11/29/2022
• Device Catalogue Number: 71303203
• Device Lot Number: 12MT26302
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 04/08/2019; 04/08/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 06/02/2019; 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1