MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6260-9-340
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	01/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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
As reported: "dislocating left total hip.Switched femoral head from +8 to +12." spoke to rep.The femoral head dislocated from a competitor liner.
Event or Problem Description
As reported: "dislocating left total hip.Switched femoral head from +8 to +12." spoke to rep.The femoral head dislocated from a competitor liner.
Additional Manufacturer Narrative
An event regarding dislocation involving a metal head was reported.The event was confirmed through clinician review of the [provided medical records.Method & results: -device evaluation and results: not performed as no product was returned for evaluation.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: review of these records confirm the patient underwent hip revision for recurrent hip dislocations.The patient had had multiple risk factors including previous revision surgeries, previous infection, a trochanteric non-union, rheumatoid arthritis and multiple sclerosis.Anyone of these conditions could alone, or in combination, affect the soft tissues and musculature supporting the stability of the hip leading to recurrent dislocation.-device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: a review of the provided medical records and x-rays by a clinical consultant indicated: review of these records confirm the patient underwent hip revision for recurrent hip dislocations.The patient had had multiple risk factors including previous revision surgeries, previous infection, a trochanteric non-union, rheumatoid arthritis and multiple sclerosis.Anyone of these conditions could alone, or in combination, affect the soft tissues and musculature supporting the stability of the hip leading to recurrent dislocation.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: V40 COCR LFIT HEAD 40MM/+8
• 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: 9726793
• Report Number: 0002249697-2020-00344
• Device Sequence Number: 2139861
• Product Code: LPH
• UDI-Device Identifier: 07613327032765
• UDI-Public: 07613327032765
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020

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: 10/31/2016
• Device Model Number: 6260-9-340
• Device Catalogue Number: 6260-9-340
• Device Lot Number: MKND7W
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 05/11/2020
• 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: 72 YR
• Patient Weight: 106