MAUDE Adverse Event Report: . OXFORD PKS COCR SIZE A LM STD

Model Number N/A

Device Problem Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 06/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that when implant was opened it was found that the seal had broken.There was no vacuum seal on this implant, all other packaging around the implant was intact.

Event Description

It was reported that when implant was opened it was found that the seal had broken.There was no vaccum seal on this implant all other packaging around the implant was intact.

Manufacturer Narrative

(b)(4).The follow up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from customer.Device history record (dhr) was reviewed and no discrepancies were found.A review of the complaint database over the last 3 years has found no similar complaints reported with this item # lot # combination.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The reported event (damaged inner barrier) has been confirmed through visual inspection of returned product, which confirms the inner sterile barrier (pouch) is damaged.The likely condition of the device when it left zimmer biomet cannot be determined.The damage to the pouch appears to have been caused by a sharp object, such as a knife or scissors.As the pouch is outside of the blister, it cannot be confirmed if the damage was caused during manufacture or following distribution.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Event Description

It was reported that when implant was opened it was found that the seal had broken.There was no vaccum seal on this implant all other packaging around the implant was intact.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Event Description

It was reported that when implant was opened it was found that the seal had broken.There was no vaccum seal on this implant all other packaging around the implant was intact.

• Brand Name: OXFORD PKS COCR SIZE A LM STD
• Manufacturer (Section D): .; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7645628
• MDR Text Key: 112847741
• Report Number: 3002806535-2018-00914
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 154718
• Device Lot Number: 3002774
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 65 YR