MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +12 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6260-9-432
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
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 supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
It was reported that a patient of exeter prosthesis is fractured at the neck.2 additional operations have taken place.Revision operation is planned for friday b)(6) 2019.
Additional Manufacturer Narrative
An event regarding crack/fracture of an exeter stem was reported.Conclusion: based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event.Visual inspection stated 'damage was observed on the articulating surface of the head, consistent with contact against a hard object' however, this did not contribute to the over all event.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
It was reported that a patient of exeter prosthesis is fractured at the neck.2 additional operations have taken place.Revision operation is planned for (b)(6) 2019.

• Brand Name: 32MM +12 LFIT V40 HEAD
• 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: 8528137
• Report Number: 0002249697-2019-01674
• Device Sequence Number: 1885212
• Product Code: LPH
• UDI-Device Identifier: 07613327013153
• UDI-Public: 07613327013153
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019

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 Expiration Date: 09/30/2020
• Device Catalogue Number: 6260-9-432
• Device Lot Number: 52916001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 10/02/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 57 YR