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

Catalog Number	6260-9-232
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Foreign Body In Patient (2687)
Date of Event	06/11/2018
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
Disassociation of trunion/femoral head.Patient identified after 2007 primary hip surgery.Patient required revision hip surgery.
Event or Problem Description
Disassociation of trunion/femoral head.Patient identified after 2007 primary hip surgery.Patient required revision hip surgery.
Additional Manufacturer Narrative
An event regarding disassociation involving a metal head was reported.The event was confirmed.Confirmed: through review of the provided medical records and x-rays by a clinical consultant.Method & results: -device evaluation and results: not performed as product was not returned -medical records received and evaluation: a review of the provided x-rays by a clinical consultant indicated: the event is confirmed on both explant picture and post event x-ray with a pencil-shaped defect of the trunnion with metal substance loss, visible as metallic debris in and around the joint space.The cause of the problem is less obvious.Sometimes component malposition or ectopic bone formation are responsible for an overload condition but in this patient there are no clear procedure-related factors evident.Component position appears fairly adequate with cup inclination and anteversion in the ¿normal range¿ although no lateral x-ray is available to verify this with the patient¿s hip anatomy.Component malposition can thus not be excluded but there is no evidence to support this.Otherwise absent clinical or other relevant information and consequently can this case not be solved with the current information.More x-ray information including early post implantation and lateral hip views would be helpful.-device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: while the event was confirmed the root cause could not determined because because insufficient information was provided.Additional information, including more x-ray information including early post implantation and lateral hip views are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: 32MM +4 LFIT V40 HEAD
• 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: 7659722
• Report Number: 0002249697-2018-02059
• Device Sequence Number: 13689299
• Product Code: JDI
• UDI-Device Identifier: 07613327013085
• UDI-Public: 07613327013085
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2018

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: 6260-9-232
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 08/20/2018
• 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: 81 YR
• Patient Weight: 100