MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA V40-FEMORAL HEAD 32MM, +4MM NK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6565-0-232
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	11/06/2007
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is being performed in an attempt to identify the cause of the event.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Should additional information become available it will be reported in a supplemental report.Device not available.
Event or Problem Description
This pi is for revision due to dislocation.Patient called stated he had a left hip replacement done on (b)(6) 2007.He stated he had a dislocation a few days after his surgery, and was revised on (b)(6) 2007.Patient did not specify if the head came out of the liner or the liner came out of the shell.He reported that he is currently feeling pain and discomfort and would like to know if his implants are part of a recall.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving ceramic head was reported.The event was confirmed by medical review.Method & results: device evaluation and results: not performed as product was not returned.A review of the provided medical records and x-rays by a clinical consultant indicated there is no documented follow-up between (b)(6) 2008 and presentation on (b)(6) 2019, when x-rays noted ¿advanced osteoarthritis of the right hip and a left total hip arthroplasty with medial and lateral heterotopic ossification with femoral acetabular bridging¿.There is no documented complaint of pain in the left hip or indication of any clinical problems referable to the recalled left femoral head.The early post-operative dislocation likely resulted from an acetabular position more vertical than nominal and was addressed with acetabular repositioning, a larger head, and adductor tenotomy.There is no examination of the explanted components, but there is no indication that the dislocation resulted from factors of implant design, manufacturing or materials.The alleged pain in the left hip, which was not documented, could relate to the advanced heterotopic ossification noted.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: a review of the provided medical records and x-rays by a clinical consultant indicated "the early post-operative dislocation likely resulted from an acetabular position more vertical than nominal and was addressed with acetabular repositioning, a larger head, and adductor tenotomy".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
This pi is for revision due to dislocation; patient called stated he had a left hip replacement done on (b)(6) 2007.He stated he had a dislocation a few days after his surgery, and was revised on (b)(6) 2007.Patient did not specify if the head came out of the liner or the liner came out of the shell.He reported that he is currently feeling pain and discomfort and would like to know if his implants are part of a recall.

• Brand Name: ALUMINA V40-FEMORAL HEAD 32MM, +4MM NK
• 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: 9079439
• Report Number: 0002249697-2019-03225
• Device Sequence Number: 16722544
• Product Code: JDI
• UDI-Device Identifier: 04546540390509
• UDI-Public: 04546540390509
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

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: 08/31/2012
• Device Catalogue Number: 6565-0-232
• Device Lot Number: 24005801
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 11/14/2019
• 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: 14 YR
• Patient Weight: 96