MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PH3 CEMENTLESS FEM SZ L PC/HA; UNICONDYLAR KNEE PROSTHESIS

Model Number N/A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Postal code: (b)(6).Occupation: qa specialist.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during incoming inspection the outer package and the sterile package was penetrated.However, the shrink wrap was intact.

Event Description

It was reported that during incoming inspection the outer package and the sterile package was penetrated.However, the shrink wrap was intact.

Manufacturer Narrative

(b)(4) this final report is being submitted to relay additional information.G3: report source, foreign - event occurred in japan.Product was returned to biomet uk for investigation and the evaluation summary is as follows: the event reports that the outer sterile packaging (tyvek lid) and the outer box is damaged.This event was identified at a zb distribution centre.There is no patient involvement.The complaint has been confirmed following review of the returned packaging and photographs provided, which confirmed the outer sterile packaging (tyvek lid) and outer box is damaged.The damage to both is similar in appearance and suggests that the outer box has been struck, which has also damaged the tyvek lid.A review of the device history records did not identify any discrepancies that would have contributed to the reported event.A complaint history review identified no similar complaints for the same item number.A complaint history review identified no similar complaints for the same lot number.The reported event is covered by inst 4.4.1.9 input output risk table ¿ sterile device packaging, revision 03.The severity of the reported event and the calculated occurrence are in line with this risk file.The overall risk score is negligible.This device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.The ifu provided with the device states to check the packaging for damage before use.The likely condition of the device when it left zimmer biomet is conforming to specification.The correct packaging materials and procedures have been used during the packaging process.The likely cause of the reported event is that the outer box has been struck during transit or storage.No corrective action required.The device appears to have been struck with something which has caused both the outer packaging and tyvek lid to become damaged.This has likely occurred during transit or handling.Therefore, it is likely that the device was distributed within specification.Risk assessment: the occurrence of the event and the risk is been assessed against the risk management report.The event is within the acceptable limits of the risk management report.Corrective action taken: no corrective action required.The device appears to have been struck with something which has caused both the outer packaging and tyvek lid to become damaged.This has likely occurred during transit or handling.Therefore, it is likely that the device was distributed within specification.Preventive action taken: no preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OXFORD PH3 CEMENTLESS FEM SZ L PC/HA
• Type of Device: UNICONDYLAR KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9897501
• MDR Text Key: 199066868
• Report Number: 3002806535-2020-00193
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 154927
• Device Lot Number: 6703363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1