MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP XLPE INSERT 51/28 NON-CEM; PRSTHSS,HIP,SM-CONSTRAINED,MTL/POLYMER,PRS UNCMNTD

Model Number	75018957
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, after the surgeon fixed the shell to the acetabulum, the nurse figured out that the insert is re-sterilized manually before not supplied with the company¿s seal on the product as usual.Thr finished with same device, no substantial delays were reported.
Additional Manufacturer Narrative
It was reported that during procedure, after the surgeon fixed the shell to the acetabulum, the nurse opened the box for the xlpe insert (75018957) and found the sterilization package to be different.According to the complainant, the pouch looked like the normal cssd pouch.This created doubts if the insert was re-sterilized manually.It was reported that the device intended for use in treatment was implanted.It was therefore not returned for investigation.A review of the complaint history revealed no additional complaint for the batch in question nor similar issues for the device in scope.A review of the batch record revealed no deviations from the standard manufacturing process.Pictures of the device packaging were sent for investigation.It was confirmed by a packaging engineer that the picture shows the correct packaging system.Furthermore, provided pictures of other packaged xlpe inserts (at the supplier) did not show any deviations from the standard s+n packaging system.The packaging of the xlpe insert differs from the packaging of the pe inserts.Pe inserts are packaged in a triple pa-pe pouch system, whereas the xlpe insert is packaged in a triple paper pouch system.If the hospital normally uses pe inserts and just recently changed to xlpe inserts, this might have contributed to the confusion with the paper packaging.Furthermore hospitals mostly use paper pouches for internal sterilization (cssd), which was probably the reason why it was assumed that the device was re-sterilized internally.The ifu (b)(4) states the following in regards to sterilization/ re-sterilization: "implants provided as sterile must not be re-sterilized by the purchaser".It is therefore highly recommended to not implant a device if there are any doubts that it could have been re-sterilized.Based on the conducted investigation it can be confirmed that the packaging system of the implanted xlpe insert was the original s+n packaging.No device problem could be identified.The need for corrective action is not indicated.Nevertheless, smith and nephew will continue to monitor the device for similar issues.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).Corrected data in h6 (medical device problem code).
Additional Manufacturer Narrative
It was reported that during procedure, after the surgeon fixed the shell to the acetabulum, the nurse opened the box for the xlpe insert (75018957) and found the sterilization package to be different.According to the complainant, the pouch looked like the normal cssd pouch.This created doubts if the insert was re-sterilized manually.It was reported that the device intended for use in treatment was implanted.It was therefore not returned for investigation.A review of the complaint history revealed no additional complaint for the batch in question nor similar issues for the device in scope.A review of the batch record revealed no deviations from the standard manufacturing process.Pictures of the device packaging were sent for investigation.It was confirmed by a packaging engineer that the picture shows the correct packaging system.Furthermore, provided pictures of other packaged xlpe inserts (at the supplier) did not show any deviations from the standard s+n packaging system.The packaging of the xlpe insert differs from the packaging of the pe inserts.Pe inserts are packaged in a triple pa-pe pouch system, whereas the xlpe insert is packaged in a triple paper pouch system.If the hospital normally uses pe inserts and just recently changed to xlpe inserts, this might have contributed to the confusion with the paper packaging.Furthermore hospitals mostly use paper pouches for internal sterilization (cssd), which was probably the reason why it was assumed that the device was re-sterilized internally.The ifu (b)(4) states the following in regards to sterilization/ re-sterilization: "implants provided as sterile must not be re-sterilized by the purchaser".It is therefore highly recommended to not implant a device if there are any doubts that it could have been re-sterilized.Based on the conducted investigation it can be confirmed that the packaging system of the implanted xlpe insert was the original s+n packaging.No device problem could be identified.The need for corrective action is not indicated.Nevertheless, smith and nephew will continue to monitor the device for similar issues.

• Brand Name: POLARCUP XLPE INSERT 51/28 NON-CEM
• Common Device Name: PRSTHSS,HIP,SM-CONSTRAINED,MTL/POLYMER,PRS UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10411814
• Report Number: 9613369-2020-00157
• Device Sequence Number: 19557901
• Product Code: LPH
• UDI-Device Identifier: 07611996111477
• UDI-Public: 07611996111477
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/15/2020

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 Model Number: 75018957
• Device Catalogue Number: 75018957
• Device Lot Number: B2000074
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 07/21/2020; 12/02/2020; 12/15/2020
• Initial Report FDA Received Date: 08/15/2020
• Supplement Report FDA Received Date: 09/28/2020; 12/08/2020; 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1