MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HEAD 36MM +8; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71303608
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	10/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
*us legal* it was reported that, after a r3-tha in (b)(6) 2017, plaintiff presented metallosis.Plaintiff underwent revision surgery on (b)(6) 2021.Plaintiff outcome is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
*us legal* it was reported that, after a r3-tha in (b)(6) 2017, plaintiff presented metallosis.Plaintiff underwent revision surgery on (b)(6) 2021.Plaintiff outcome is unknown.
Event or Problem Description
It was reported that, after a primary right r3-tha surgery in (b)(6) 2017, the plaintiff presented metallosis, significant pain, edema, and mechanical complications.As a result, the plaintiff underwent revision surgery on (b)(6) 2021.During the revision, corrosion was found at the neck and head junction.The femoral component and the acetabular shell were well fixed and were left in place.The liner and the femoral head were explanted and replaced with a tha system from a competitor.The plaintiff tolerated the procedure well.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
H10: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that the reported pain, elevated cobalt and intraoperative findings of ¿slightly cloudy, yellow joint fluid, grossly thickened capsule, and corrosion at the head and neck junction may be consistent with the reported metallosis.However, the root cause of the reported clinical findings cannot be confirmed but based on the intraoperative findings of corrosion on the trunnion is a likely source of the metal debris.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted at this time.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 complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed that fracture of implant components has been identified as a possible adverse effect.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include damaged product, implant corrosion or wear.The contribution of the device to the reported event could not be corroborated.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 is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Internal complaint reference number: (b)(4).

• Brand Name: COCR 12/14 FEM HEAD 36MM +8
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13814683
• Report Number: 1020279-2022-01229
• Device Sequence Number: 2068652
• Product Code: JDG
• UDI-Device Identifier: 03596010480002
• UDI-Public: 03596010480002
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K022902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/27/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71303608
• Device Catalogue Number: 71303608
• Device Lot Number: 17CM00646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2022
• Supplement Date Received by Manufacturer: 02/25/2022; 03/21/2022; 04/22/2022
• Initial Report FDA Received Date: 03/18/2022
• Supplement Report FDA Received Date: 03/21/2022; 03/30/2022; 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71332752 / R3 0 DEG XLPE ACET LNR / 16LM14840.; 71335552 / R3 3 HOLE ACET SHELL 52MM / 17BM08020A.; 71356006 / ANTHOLOGY SO POROUS SIZE 6 / 16FM14196.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female