MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS INTEGR MIA STEM WITH TI/HA 7; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number 75000180

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during a tha surgery, a perforation of the inner peel pouch of the sl-plus integr mia stem with ti/ha 7 was noticed.The procedure was finished with a smith and nephew back up device with a five minutes delay.No further complications were reported.

Manufacturer Narrative

H6: it was reported that, during a total hip replacement surgery, a perforation of the inner peel pouch of the sl-plus integr mia stem with ti/ha 7 was noticed.The device, intended for use in treatment, was returned for investigation.Upon visual inspection, the reported complaint issue could be confirmed.The seal of the innermost peel-pouch is punctured.A relationship between the reported event and the device can therefore be confirmed.A review of the production documentation, including the packaging documentation at the packaging supplier was performed and no deviations were detected, that could have contributed to the reported failure mode.A complaint history review on batch as well as on family level was performed.No additional complaints for the batch in question were detected.Furthermore, for the part family in scope, the occurrence and severity are in line with the corresponding risk file.A review of past corrective actions was performed.No further escalation is required.Additionally, a risk review was performed.The risk of a damaged device packaging is covered in our corresponding risk file and rated as low.The external packaging supplier performed a thorough investigation.According to this analysis, two imprints of the shaft are visible in the innermost peel pouch.The first one of the original position and a second imprint of the tip of the shaft lies on the distal sealing seam of the bag.The folding box was supplied as well but it shows no external deformations or damages.On the inside (distal seal seam), however, a small hole can be seen at the front.A dye leak test revealed that the peel pouch is no longer airtight at another site as well, regardless of the punctured seam which caused the complaint.The fact that the folding box was perforated on the inside at the front could be in indications of an impact during transport.An unusual heavy impact could then lead to a damaged peel pouch which subsequently results in a loss of vacuum.The other traces suggest that the shaft moved within the primary bag and thus punctured the lower weld seam.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution and the need for corrective action is not indicated.In the current instruction for use for hip implants it is mentioned that the device should not be used if the packaging shows any damage.Smith + nephew will continue to monitor this device for similar issues.No further actions are deemed necessary to this time.This investigation is considered closed.The returned device will be discarded.Internal complaint reference number: case-(b)(4).

• Brand Name: SL-PLUS INTEGR MIA STEM WITH TI/HA 7
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14739802
• MDR Text Key: 296239036
• Report Number: 9613369-2022-00313
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 07611996092820
• UDI-Public: 07611996092820
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75000180
• Device Catalogue Number: 75000180
• Device Lot Number: D2139884
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1