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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Metal Related Pathology (4530)
Date of Event	02/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (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 in the literature review "metallosis after hip arthroplasty: two case reports", 1 patient suffered 2 dislocations (unknown in which implants) the first 8 years later and the second 9 years and 7 months later of the right initial r3-tha surgery.At the time of the second dislocation, radiographs suggested radiolucency in the greater trochanter and soft tissue darkening and mineralization anterior to the joint.Mri imaging revealed complex multiloculated fluid collections suggesting an extensive pseudotumor.Six weeks after confirmation of pseudotumor, the patient underwent complete excision of the pseudotumor followed by revision of right r3-tha and reconstruction of the abductor mechanism.During revision surgery, trunnion wear with black deposits on the femoral neck was observed.At 6 weeks follow-up patient was recovering well.There's no more available info.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation but the pictures were reviewed, and the trunnion wear was confirmed.The clinical/medical investigation concluded that, per the complaint details, no further information is available.Consequently, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical 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 revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, 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 revealed that dislocations, subluxation, decreased range of motion, or lengthening or shortening of the femur can occur has been identified as a potential complications associated with total hip arthroplasty surgery, primary or revision.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 traumatic injury, patient anatomy, friction, joint tightness, excessive forces, abnormal loading, damaged product or wear.The contribution of the device to the reported incident could be corroborated as it was required a revision surgery to treat this event.Based on this investigation, the need for corrective action is not indicated.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: 14520062
• Report Number: 1020279-2022-02626
• Device Sequence Number: 6530294
• 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): 06/20/2022

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 Expiration Date: 05/17/2020
• Device Model Number: 71303204
• Device Catalogue Number: 71303204
• Device Lot Number: 10EM11629
• 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: 05/03/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2010
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female