MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER 37.5 L125 V40 TRIAL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	0581-3-371
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records indicates that devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that, during a product assembly on a tray, our staff found no engraving on the stem trial.
Event or Problem Description
It was reported that, during a product assembly on a tray, our staff found no engraving on the stem trial.
Additional Manufacturer Narrative
An event regarding a missing etching involving an exeter trial was reported.The event was confirmed.Method & results: device evaluation and results: the reported device was reviewed by an sme at the lisi manufacturing site who observed the following; visual inspection: the engraving is missing on both sides of on part reference 0581-3-371, lot number g7038642.Medical records received and evaluation: not performed as there was no patient involvement.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: an investigation conducted by the manufacturing site lisi documented the following; the investigation concluded that the operator has left part in the basket and did not perform the engraving.The ncr was raised to investigate the issue.Corrective action/preventive action: nc was initiated to address the issue, with an use as is disposition.

• Brand Name: EXETER 37.5 L125 V40 TRIAL
• 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: 8091047
• Report Number: 0002249697-2018-03781
• Device Sequence Number: 1406555
• Product Code: LPH
• UDI-Device Identifier: 07613327123784
• UDI-Public: 07613327123784
• Combination Product (Y/N): N
• PMA/510(K) Number: K153345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2019

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: Health Professional
• Device Catalogue Number: 0581-3-371
• Device Lot Number: G7038642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 01/28/2019
• 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