MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	0580-1-373
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	05/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
When the stem package was opened during surgery, it was noticed that the spigot at the neck was not in the package.There was no surgical delay because the staff just opened another stem package.
Additional Manufacturer Narrative
An event regarding a missing spigot protector for an exeter stem was reported.The spigot was not returned in the packaging, however the event could not be confirmed to be a manufacturing related issue.Device evaluation and results: visual inspection was carried out on the returned part.The photograph noted that the spigot was missing as was some of the packaging foam.Medical records received and evaluation: not performed as no adverse consequences to the patient were noted and no medical records were provided.Device history review: all devices in the reported lot 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.Conclusions: the investigation performed by the supplier concluded "no action is required at this time as there was no indication of a manufacturing issue.This complaint was presented to the exeter stem packaging operators.Lmo qa product surveillance will continue to monitor for trends".No further investigation is required at this time if further information becomes available this investigation will be re-opened.
Event or Problem Description
When the stem package was opened during surgery, it was noticed that the spigot at the neck was not in the package.There was no surgical delay because the staff just opened another stem package.

• Brand Name: EXETER V40 STEM 37.5MM NO 3
• 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: 6600596
• Report Number: 0002249697-2017-01729
• Device Sequence Number: 767856
• Product Code: LPH
• UDI-Device Identifier: 04546540153272
• UDI-Public: (01)04546540153272(1)161119(17)211130
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2017

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 Expiration Date: 11/30/2021
• Device Model Number: 0580-1-373
• Device Catalogue Number: 0580-1-373
• Device Lot Number: G6169618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Initial Date Received by Manufacturer: 05/04/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 05/31/2017
• Supplement Report FDA Received Date: 09/18/2017
• 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