MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT EON 127; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6097-0835
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Primary procedure, left hip.It was reported that after removing the outer sterile blister from the pristine outer box, the tyvek covering was observed to have holes.The outer blister was opened and holes were also observed on the tyvek of the inner sterile blister.Due to sterility concerns, the device was not used.Surgeon decided to implant a size 7 stem instead of the original size 8 as the device was readily available in the operating room rep reported that there was no surgical delay.The device and sterile blisters are available for return, but the hospital disposed of the outer box.The implant was not listed on the implant sheet as a wasted/ in and out device.Rep was present for the procedure and witnessed the event.Rep reported that x-rays, medical records, and additional information will not be released by the hospital or surgeon.
Additional Manufacturer Narrative
An event regarding packaging issue, holes in the tyvek sheets, involving an omnifit stem was reported.The event was confirmed by product inspection.Method & results: product evaluation and results: the package was returned with only the product labels, inner and outer blister and tyvek sheets.The inner tyvek sheet was still sealed when the device was received.There are two holes that are near the patient labels on the outer tyvek sheet and they match the holes on the inner tyvek sheet.The holes seem to be pushing inward, even the plastic protection inside the packaging is damaged.Although there is no hole, the damage is in the same location underneath the two tyvek sheets.The box was not returned nor were images provided.Clinician review: not performed as medical records were not provided for review.Product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the internal contents of the box were returned which confirm the reported event of holes in the tyvek sheets however, the root cause could not be determined as the outer box was not returned.Further evaluation was conducted with the packaging team sme's and they noted that a defect like this would be noticed as per their visual inspection criteria and have been rejected.The packaging team also noted their procedures for sealing packages all have a section for visual inspection.The appendix is for a "visual appearance acceptance criteria" workflow for sealed products.If there is any visible defects, i.E.Smudge, burn, pinholes, tears or other obvious defects, the package shall be rejected.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Primary procedure, left hip.It was reported that after removing the outer sterile blister from the pristine outer box, the tyvek covering was observed to have holes.The outer blister was opened and holes were also observed on the tyvek of the inner sterile blister.Due to sterility concerns, the device was not used.Surgeon decided to implant a size 7 stem instead of the original size 8 as the device was readily available in the o.R.Rep reported that there was no surgical delay.The device and sterile blisters are available for return, but the hospital disposed of the outer box.The implant was not listed on the implant sheet as a wasted/ in and out device.Rep was present for the procedure and witnessed the event.Rep reported that x-rays, medical records, and additional information will not be released by the hospital or surgeon.

• Brand Name: OMNIFIT EON 127
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8319107
• Report Number: 0002249697-2019-00769
• Device Sequence Number: 19404498
• Product Code: JDI
• UDI-Device Identifier: 07613327022391
• UDI-Public: 07613327022391
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K983226
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2019

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: No Information
• Device Expiration Date: 08/30/2023
• Device Catalogue Number: 6097-0835
• Device Lot Number: 5E8106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Initial Date Received by Manufacturer: 01/13/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR