MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	0580-1-371
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The customer reported that during a revision case, the surgeon had planned to revise a cup and when the patient was opened, he realized that the stem would also need revising.The exeter stem was difficult to remove.It had to be removed using a flexible osteotome and the removal process added 20 minutes to the surgery.The customer alleges that the stem was tarnished and that this makes the stem more likely to stick in the femoral canal because the polished surface is not longer there and that, had the device been made of cocr, then the tarnishing would not have occurred.
Additional Manufacturer Narrative
An event regarding an appearance issue involving an exeter stem was reported.The event was confirmed though visual inspection of the device.Method & results: -device evaluation and results: visual inspection: visual inspection was performed as part of the material evaluation and indicated the following comments: ma: damage observed on the stem consistent with the cement-mantle breakdown process.Explantation damage also observed on the stem.Based on the given information, no identifiable materials or manufacturing discrepanices were observed on the surfaces examined.Medical records received and evaluation: no medical records were received for review with a clinical consultant 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: the investigation concluded that 'damage observed on the stem consistent with the cement-mantle breakdown process.' no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The customer reported that during a revision case, the surgeon had planned to revise a cup and when the patient was opened, he realized that the stem would also need revising.The exeter stem was difficult to remove.It had to be removed using a flexible osteotome and the removal process added 20 minutes to the surgery.The customer alleges that the stem was tarnished and that this makes the stem more likely to stick in the femoral canal because the polished surface is not longer there and that had the device been made of cocr then the tarnishing would not have occurred.

• Brand Name: EXETER V40 STEM 37.5MM NO 1
• 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: 8091558
• Report Number: 0002249697-2018-03789
• Device Sequence Number: 1498218
• Product Code: JDI
• UDI-Device Identifier: 04546540153258
• UDI-Public: 04546540153258
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K173499
• 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): 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0580-1-371
• Device Lot Number: GA666623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 02/07/2019
• 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: 79 YR