MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71302608
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Joint Dislocation (2374)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, after total hip replacement was performed on (b)(6) 2022, the patient experienced an unspecified infection.This adverse event was treated by performing a revision surgery on (b)(6) 2022 ((b)(4)), in which the poly ring was observed to be disassembled from the cup ((b)(4)).The femoral head and the stem were explanted as well.In addition, when the patient was moved to bed at the operating room, hip dislocation was found.Patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on a review of this complaint, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported events including the revision cannot be determined and the patient¿s current health status remains unknown.Therefore, no further clinical/medical assessment can be rendered at this time.Should any additional relevant medical information be provided, this case could be re-assessed.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 endoprostheses systems revealed that both acute postoperative wound infection and late deep sepsis has been identified as a adverse effect.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the sterilization records revealed the batch was sterilized within normal parameters.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 are not limited to loss of sterility during procedure, patient reaction, and post-operative healing issue.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.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.
Additional Manufacturer Narrative
D8 / d9: date device returned to manufacturer, pma/510(k)number b5- describe event or problem.D1: brand name.D4: catalog number, lot number, expiration date, unique identifier (udi) #.D10: concomitant medical products and therapy dates.G2: report source.H3: device evaluated by manufacturer.H6: health effect - clinical code.
Event or Problem Description
It was reported that, after a hip hemiarthroplasty was performed on (b)(6) 2022, the patient experienced an unspecified infection.This adverse event was treated by performing a revision surgery on (b)(6) 2022.Patient's current health status is unknown.
Additional Manufacturer Narrative
Additional information: d4, h4 h3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on a review of this complaint, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported events including the revision cannot be determined and the patient¿s current health status remains unknown.Therefore, no further clinical/medical assessment can be rendered at this time.A review of the production order 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 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 endoprostheses systems revealed that both acute postoperative wound infection and late deep sepsis have been identified in adverse effects.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.A review of the sterilization records revealed the batch was sterilized within normal parameters.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include loss of sterility during procedure, post-operative healing issue, patient condition and/or medical history.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.B5, h6, h10.
Event or Problem Description
It was reported that, after a hip hemiarthroplasty was performed on (b)(6) 2022, the patient experienced an unspecified infection.This adverse event was treated by performing a revision surgery on (b)(6) 2022 ((b)(4)), in which the poly ring was observed to be disassembled from the cup ((b)(4)).The femoral head and the stem were explanted as well.In addition, when the patient was moved to bed at the operating room, hip dislocation was found.Patient's current health status is unknown.
Additional Manufacturer Narrative
Additional information: h6, h10 h3, h6: the associated devices were returned.The visual inspection of the femoral head, shell and liner reveal some scratches on the devices.The clinical/medical investigation concluded that, based on a review of this complaint, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported events including the revision cannot be determined and the patient¿s current health status remains unknown.Therefore, no further clinical/medical assessment can be rendered at this time.Should any additional relevant medical information be provided, this case could be re-assessed.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 numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed devices.A review of the instructions for use documents for endoprostheses systems (liner) revealed that infection, both acute postoperative wound infection and late deep sepsis, can occur, this has been identified as adverse effects.A review of the instructions for use documents for total hip systems (head) revealed that potential complications associated with total hip arthroplasty surgery, primary or revision as infection, both early, post-operative superficial and early, post-operative deep wound infection and late periprosthetic infection can occur.A review of the instructions for user of the stem states infection, joint instability and joint infection as a ¿potential adverse device effect¿ in combination with the implantation of a hip prosthesis.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 these products and event.A review of the sterilization records revealed the batches were sterilized within normal parameters.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 loss of sterility during procedure, post-operative healing issue, injury, patient condition and/or medical history.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: COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 8
• 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: 15294061
• Report Number: 1020279-2022-03840
• Device Sequence Number: 2805938
• Product Code: LPH
• UDI-Device Identifier: 03596010194091
• UDI-Public: 03596010194091
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/29/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71302608
• Device Catalogue Number: 71302608
• Device Lot Number: 20AM03571
• 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: 08/02/2022
• Supplement Date Received by Manufacturer: 09/23/2022; 03/31/2023; 04/25/2023; 06/23/2023
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 09/26/2022; 04/03/2023; 05/22/2023; 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2020
• 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: 71302608/COCR 12/14 FEM HEAD 26 + 8; 71325049/21DM20302/TNDM BP SHL/XLPE LNR; 75000180/B1613700/SL-PLUS INTEGR MIA STEM; 75000180/SL-PLUS INTEGR MIA STEM WITH TI/HA 7
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male