MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 44MM/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-9-244
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Inflammation (1932); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's right hip was revised due to dissociation of the head from the stem.Intra-operatively, black tissue and fluid was noticed, as well as the trunnion having been worn down to a point.The stem, head and liner were revised to a restoration modular stem construct, ceramic head, adm/ mdm poly insert, and mdm metal liner.
Additional Manufacturer Narrative
Reported event: an event regarding revision due to disassociation between stem and metal head, and fretting was reported.The event was confirmed based on medical review.Method & results: not performed as product was not returned.Clinical review: a review of the provided medical records and x-rays rejected by a clinical consultant indicated: undated x-ray: ap right hip notes uncemented tha with modular head in acetabular component, trunnion disassociated and dislocated from modular head with superior trunnion erosion noted.No clinical or pmh, no patient demographics, no operative reports, no dated serial x-rays, no examination of explanted components, no lab or pathology reports.Based upon the single x-ray, the event description appears to be confirmed, but insufficient data is presented to confirm the event description to create a medical report for this case.-product 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.Conclusions: an event regarding revision due to disassociation between stem and metal head, and fretting was reported.The event was confirmed based on medical review.The exact cause of the event could not be determined because insufficient information was provided.Further information is needed to complete the investigation for determining its root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's right hip was revised due to dissociation of the head from the stem.Intra-operatively, black tissue and fluid was noticed, as well as the trunnion having been worn down to a point.The stem, head and liner were revised to a restoration modular stem construct, ceramic head, adm/ mdm poly insert, and mdm metal liner.

• Brand Name: V40 COCR LFIT HEAD 44MM/+4
• 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: 11001128
• Report Number: 0002249697-2020-02659
• Device Sequence Number: 703903
• Product Code: JDI
• UDI-Device Identifier: 07613327032758
• UDI-Public: 07613327032758
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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: 06/30/2016
• Device Model Number: 6260-9-244
• Device Catalogue Number: 6260-9-244
• Device Lot Number: MKJ330
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 01/25/2021
• 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: 76 YR