MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 OFFSET IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 71368569

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/30/2023

Event Type  Injury  

Event Description

It was reported that, during a thr surgery, performed on (b)(6) 2023, it was noticed that the welded piece of another r3 offset impactor got broken and went missing, after being used.The staff was alerted and a visual inspection was performed for the missing piece of the impactor.The surgeon could not find the missing piece and proceeded with the procedure.Fluoroscopy was used multiple times during the procedure and no evidence of the foreign body was noticed.Surgery was completed after a non-significant delay.Upon a follow up visit with the surgeon, the patient´s x-rays revealed a small foreign body near the acetabular component.The patient was scheduled for a secondary surgery to remove the foreign body on (b)(6) 2023.The revision surgery confirmed that the foreign body was a small circular piece of the reported impactor.The piece was removed and a new femoral head and xlpe insert were placed.Interoperative x-rays confirmed that no further foreign bodies were present and the surgery was completed.The patient is in good health and recovering normally post tha surgery.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Manufacturer Narrative

D10: device available for evaluation? , e4: initial reporter also sent report to fda, and h3: the sample is under evaluation by manufacturing site.Mdr report #: mw5145682 h6: health effect - impact code.

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals a welded piece on the device broke off.This piece was not returned.The device shows significant wear and use.A review of complaint history based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.The clinical/medical evaluation concluded that it was reported during thr surgery (b)(6) 2023, it was noticed that the welded piece of an r3 offset impactor got broken and went missing.After a search the missing piece could not be found.Surgery was completed after a non-significant delay.Subsequent x-rays revealed a small foreign body near the acetabular component.The patient had a revision (b)(6) 2023, the piece was removed and a new femoral head and xlpe insert were placed.X-rays confirmed that no further foreign bodies were present.It is noted medical records.As of the date of this medical investigation, the requested supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the reported broken r3 offset impactor and subsequent revision.With the limited information provided, the patient impact beyond the reported revision 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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 a similar event was previously identified, and prior actions were performed.It has been concluded that there is a potential for breakage if used after the expected lifetime or excessive force is used as this device is a reusable instrument and it is expected to wear over time.Also, the failure rate of this issue is within expected and documented in the risk file.The batch number under this complaint was manufactured before these actions were initiated.A review of instructions for use for care, maintenance, cleaning and sterilization of smith & nephew orthopedics devices revealed that visually inspecting for damage or wear, including components in their disassembled state prior to re-assembly as well as ensuring components are re-assembled securely is indicated.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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 future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: R3 OFFSET IMPACTOR
• Type of Device: 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: 17785902
• MDR Text Key: 323890996
• Report Number: 1020279-2023-01817
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010600240
• UDI-Public: 03596010600240
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 71368569
• Device Lot Number: 09EYW0018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 09/28/2023; 10/16/2023
• Supplement Dates FDA Received: 10/04/2023; 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: OXINIUM FEM HD 12/14 32MM -3, LOT#:23DM07304; R3 0 DEG XLPE ACET LNR 32MM X 48MM, LOT#:23EM14213
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female