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
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
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 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
• Common Device Name: 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
• Report Number: 9613369-2023-00132
• Device Sequence Number: 6126897
• Product Code: LPH
• UDI-Device Identifier: 07611996111491
• UDI-Public: 07611996111491
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 05/27/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2019
• 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
• Patient Sex: Unknown