MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X-CHANGE WALL MESH SMALL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	0942-8-025
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplement al report upon completion of the investigation.
Event or Problem Description
The customer reported that the box for a 6 petal x-change mesh had a 4 petal implant in the box.Update 23/09/2019: there was a short delay of around 5 minutes whilst they located and opened another prosthesis.
Event or Problem Description
The customer reported that the box for a 6 petal x-change mesh had a 4 petal implant in the box.Update (b)(6) 2019: there was a short delay of around 5 minutes whilst they located and opened another prosthesis.
Additional Manufacturer Narrative
An event regarding mesh with the incorrect number of petals packaged involving an exeter mesh was reported.The event was confirmed after review of device history.Records.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-product history review: on review of the device history records by lisi medical for lot id g6091225, the operator recorded 4 petals instead of the 6 petals required per the drawing.As a result, it was concluded that the entire 40 units in the reported lot g6091225 (part: 0942-8-025) are the incorrect part (0942-8-015) -complaint history review: there have been no other similar events for the lot referenced.Conclusions: the reported event of 4 petal mesh packaged instead of 6 petal mesh was confirmed after review of device history records by the lisi medical.Nc has been raised to evaluate the root cause of the event.

• Brand Name: X-CHANGE WALL MESH SMALL
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9173213
• Report Number: 0002249697-2019-03454
• Device Sequence Number: 2538092
• Product Code: LPH
• UDI-Device Identifier: 04546540167712
• UDI-Public: 04546540167712
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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: 0942-8-025
• Device Catalogue Number: 0942-8-025
• Device Lot Number: G6091225
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 10/09/2019
• Supplement Report FDA Received Date: 04/15/2020
• 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