MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP XLPE INSERT 55/28 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 75018959

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 03/07/2023

Event Type  malfunction  

Event Description

It was reported during a thr surgery, problems with the packaging of the polarcup xlpe insert 55/28 non cem device were observed as there was a hole in the first package and the final package was not open from the v shape where the opening starts from, and it was unsealed and totally open.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not injured as consequence of this problem.

Manufacturer Narrative

Internal complaint reference: (b)(4).

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 there was hole on the primary packaging, which was unsealed.However, after product receipt and evaluation, it was confirmed that there was no sterility breach on the implant packaging.The primary pouch was unsealed, but the second one (which provides an additional sterile barrier) was intact.This device issue may require use of a replacement or alternate device to complete the surgical procedure, and may result in a short delay while that alternate device is obtained.Moreover, if the device malfunction were to recur, it would not be likely to cause or contribute to a death or serious injury.

• Brand Name: POLARCUP XLPE INSERT 55/28 NON-CEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS 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: 16634990
• MDR Text Key: 312201585
• Report Number: 9613369-2023-00132
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07611996111491
• UDI-Public: 07611996111491
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75018959
• Device Catalogue Number: 75018959
• Device Lot Number: B1911655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2019
• 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