MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CPCS DIST CENT SZ 10MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71312410
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a cemented hip replacement using cpcs, the 10mm centraliser split open when fitted to the tip of the stem.This device was discarded.Another 10mm centraliser was opened.The surgeon noticed that it had abnormal material qualities "like glass".It failed in the same way, but was not thrown away - it is available for return and inspection.The surgery was completed with another s+n device.There was a delay less than or equal to 30 minutes.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is fractured and deformed.It could not be determined that all pieces were returned.The clinical / medical investigation concluded that this case reports that during a hip replacement surgery, two separate 10mm centralizers split open when fitted to the tip of the stem.Per email correspondence, all pieces were recovered from the patient and the procedure was completed using another device, with no patient injury and a minimal surgical delay.Therefore, no further clinical assessment is warranted.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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 have reason to suspect that the product failed to meet product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.The potential probable cause for this event is likely a manufacturing process error.This issue is being addressed through our internal nonconformance process.Based on this investigation, the need for corrective action is 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.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is fractured and deformed.It could not be determined that all pieces were returned.The clinical / medical investigation concluded that this case reports that during a hip replacement surgery, two separate 10mm centralizers split open when fitted to the tip of the stem.Per email correspondence, all pieces were recovered from the patient and the procedure was completed using another device, with no patient injury and a minimal surgical delay.Therefore, no further clinical assessment is warranted.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Quality hold 400001363 was issued on 15 feb.2021 for the affected batch of 50 pcs.As of 25 june 2021, there have been 13 complaints for this batch for deformation.All indicate that the part was recognized to be damaged/deformed and all complaints indicate the product was not used to complete the surgery.All complaints returned and visually verified by quality engineering were deemed obviously deformed with a high degree of detectability.At the time of this investigation, the cause of the deformation cannot be confirmed.Parts are not intended to be processed through vapor degrease.To ensure this wasn't the cause of the complaints, parts were scrapped from an unrelated xp01 (original) cpcs centralizer to test the outcome of vapor degreasing on these devices.The parts do not deform in the same way as seen in the complaints.They melt on the side contacting the metal passivation cleaning basket and become cracked and brittle.Additionally, the complaints were received from various hospitals from various countries, indicating the cause of the complaints is not linked to hospital procedure (sterilizing/autoclave/etc.).At this time, we have reason to suspect that the product failed to meet product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.The potential probable cause for this event is likely a manufacturing process error.This issue is being addressed through our internal nonconformance process.Based on this investigation, the need for corrective action is 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.
Additional Manufacturer Narrative
After further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that during a cemented hip replacement using cpcs, the 10mm centralizer split open when fitted to the tip of the stem.Another 10mm centralizer was opened, and the surgeon noticed that it had abnormal material qualities "like glass".It failed in the same way.The surgery was completed with another s+n device.There was a delay of less than or equal to 30 minutes.Upon further review, it was determined that the event does not meet reporting per 21 cfr part 803.The central stabilizer is placed outside of the patient.There is no report of patient harm.Based on health hazard evaluation, the most likely scenario for a failure is that a back-up device is available and is used to complete the surgical procedure.The worst case if no back-up is available is to use an alternate method defined in the instructions for use.

• Brand Name: CPCS DIST CENT SZ 10MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 11197402
• Report Number: 1020279-2021-00490
• Device Sequence Number: 10945037
• Product Code: JDI
• UDI-Device Identifier: 03596010466983
• UDI-Public: 03596010466983
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K970351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/06/2021

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: 71312410
• Device Catalogue Number: 71312410
• Device Lot Number: 20GM19413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 08/04/2021; 10/26/2021; 10/26/2021; 12/06/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 08/05/2021; 10/28/2021; 10/28/2021; 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2020
• 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: 71312410, LOT: 20GM19413
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown