MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HEAD 32 + 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71303204
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Joint Dislocation (2374); Metal Related Pathology (4530)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).Mastel, m., boisvert, a., moore, r., sutherland, f., & powell, j.(2022).Metallosis following hip arthroplasty: two case reports.Journal of medical case reports, 16(1), 1-9.Doi: https://doi.Org/10.1186/s13256-022-03336-4.
Event or Problem Description
"it was reported that on literature review ""metallosis following hip arthroplasty: two case reports"", one patient had a primary right hip tha surgery with a r3 acetabular shell, r3 poly liner, synergy stem and cocr femoral head.8 years after the primary surgery, the patient suffered from a dislocation and one year later, the patient sustained a second dislocation.The patient exhibited signs of metallosis and underwent a revision surgery to treat the adverse event.At 6 weeks follow-up, the patient was recovering well.
Additional Manufacturer Narrative
The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that no conclusions can be made from this publication as its limited to the information provided and further investigation is not possible.It was reported that at the 6 weeks follow-up, the patient was recovering well.No further clinical assessment is warranted at this time.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 complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for total hip systems reveal in the postoperative section that patients should be warned against unassisted activity, particularly activities requiring excessive motion of the hip, as they may result in dislocation.Also, although rare, metal sensitivity reactions have been reported in patients following joint replacement, this has been identified in the adverse events in primary and revision surgery section.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.Possible causes could include but not limited to traumatic injury, patient anatomy, abnormal loading of limb, 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.

• Brand Name: COCR 12/14 FEM HEAD 32 + 4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 14450385
• Report Number: 1020279-2022-02439
• Device Sequence Number: 6569958
• Product Code: LPH
• UDI-Device Identifier: 03596010194190
• UDI-Public: 03596010194190
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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: 71303204
• Device Catalogue Number: 71303204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/15/2022
• 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: UNKN SYNERGY HIP STEM CEM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown