MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HEAD 26 + 4; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Model Number	71302604
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a bipolar hip arthroplasty surgery that was performed on (b)(6) 2022, a revision surgery was performed on (b)(6) 2022 because the cocr 12/14 fem head 26 + 4 was disassociated from the tndm bp shl/xlpe lnr 42od 26id even though the poly ring was locked in the tandem bipolar.Patient current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the associated devices were returned and evaluated.The visual inspection did not reveal the stated failure mode.A dimensional evaluation performed on the device revealed that there was no found evidence that the head, retaining ring and tandem shell product was out of tolerance in the areas that would cause the compliant allegations.However the plastic lock ring was not in tolerance but was dimensionally distorted therefore the measurement listed for the lock ring are most likely not accurate.The liner was not removed for measurement because it would have caused damage to it causing the measurement to be out.Therefore no other orders are suspected of being affected.No need for any further actions.The clinical/medical investigation concluded that, it was reported that, after a bipolar hip arthroplasty (b)(6) 2022, a revision surgery was performed (b)(6) 2022 because the head was disassociated from the liner, even though the poly ring was locked in the tandem bipolar.Patient current health status is unknown.It is noted additional medical documentation is not available; therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the head/liner disassociation and subsequent revision cannot be determined with the limited information provided.A review of the production orders 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 head.A review of complaint history revealed similar events for the tandem shell/liner 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 (head) revealed in preoperative warnings and precautions that improper neck selection, positioning, looseness of acetabular or femoral components, extraneous bone, penetration of the femoral prosthesis through the shaft of the femur, fracture of the acetabulum, intrapelvic protrusion of acetabular component, femoral impingement, periarticular calcification, and/or excessive reaming may increase the risk of dislocations, subluxation, decreased range of motion, or lengthening or shortening of the femur, which may lead to revision surgery.The intraoperative warnings and precautions indicate that muscle looseness and/or malpositioning of components may result in loosening, subluxation and dislocation.Additionally, ectopic bone and/or bone spurs may lead to dislocation and painful or restricted motion and proper positioning of the components is important to minimize impingement which could lead to early failure, premature wear, device related noise, and/or dislocation, all of which may lead to revision surgery.Postoperative warnings and precautions highlight the need of warning patients against unassisted activity, particularly use of toilet facilities and other activities that require excessive motion of the hip, as they may result in subluxation or dislocation.A review of the instructions for use documents for endoprostheses systems (tandem shell/liner) revealed that care must be taken to assess the viability of the acetabular hyaline cartilage and the presence of any irregularity, anomaly, or surface configuration which may predispose to subluxation and/or dislocation of the prosthesis, this has been identified as a warning.A review of the risk management files 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 head and event.A review for the tandem shell/liner concluded that a similar event was found related to dislocation, and escalated actions were opened.The listed batch was not part of the impacted product.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, patient anatomy, postoperative care or abnormal loading of limb.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 HEAD 26 + 4
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• 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: 16098160
• Report Number: 1020279-2023-00035
• Device Sequence Number: 17771457
• Product Code: KWZ
• UDI-Device Identifier: 03596010194084
• UDI-Public: 03596010194084
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

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: 71302604
• Device Catalogue Number: 71302604
• Device Lot Number: 22BM13208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• 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: TNDM BP SHL/XLPE LNR 42OD 26ID, LOT#: 22HM08541
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown